dimarts, 31 de maig del 2016

Smart tampon: Startup seeks to use menstrual cycle to help Dx cervical cancer

 

Next Gen JaneA new women’s medical device company, Next Gen Jane, aims to develop a “smart tampon” that can perform blood-based tests for a range of biomarkers to improve women’s health monitoring for conditions like cervical cancer, according to a new report from FastCompany.

Founders Ridhi Tariyal and Stephen Gire, who met in an infectious disease lab at Harvard, said they were driven to develop a system of testing that would allow proactive tracking of women’s health through studying in-home blood samples.

The founders said they were stunned by the number of women’s health conditions, such as endometriosis, polycystic ovarian syndrome, uterine fibroids and cervical cancer, which can go unrecognized and threaten women’s fertility, and mortality.

“We had to come up with something that would allow women to find out about these conditions sooner than every year. You can pick up a disease any time, and letting it sit there for a year until your next visit can have consequences downstream that you don’t want. The system has to change,” CEO Tariyal told FastCompany. “I was thinking about how to get a large enough volume of blood to do this. Until I realized that we actually bleed quite a bit every month.”

The smart device could also allow women to track their fertility through the hormone anti-mullerian, which serves as a molecular biomarker for the relative size of the ovarian reserve, and can be used to predict the timing of menopause.

Next Gen Jane, still in stealth mode, hasn’t uncovered many details of how their “smart tampon” will work, but told FastCompany they recently closed a round of seed funding led by Access Industries and are conducting clinical trials to bring the device to market.

“We have to get to a place where we have working, high-quality tests for enough conditions that it actually makes it worthwhile for women to test themselves every month. Our vision is to manage reproductive health from menarche to menopause. We’re thinking about all the ways that women could find data about their bodies useful,” CEO Tariyal told FastCompany.

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Stung by Yelp reviews, health providers spill patient secrets

generic-files-1x1by Charles Ornstein, ProPublica. The story was co-published with The Washington Post.

Burned by negative reviews, some health providers are casting their patients’ privacy aside and sharing intimate details online as they try to rebut criticism.

In the course of these arguments — which have spilled out publicly on ratings sites like Yelp — doctors, dentists, chiropractors and massage therapists, among others, have divulged details of patients’ diagnoses, treatments and idiosyncrasies.

One Washington state dentist turned the tables on a patient who blamed him for the loss of a molar: “Due to your clenching and grinding habit, this is not the first molar tooth you have lost due to a fractured root,” he wrote. “This tooth is no different.” In California, a chiropractor pushed back against a mother’s claims that he misdiagnosed her daughter with scoliosis. “You brought your daughter in for the exam in early March 2014,” he wrote. “The exam identified one or more of the signs I mentioned above for scoliosis. I absolutely recommended an x-ray to determine if this condition existed; this x-ray was at no additional cost to you.”

And a California dentist scolded a patient who accused him of misdiagnosing her. “I looked very closely at your radiographs and it was obvious that you have cavities and gum disease that your other dentist has overlooked. … You can live in a world of denial and simply believe what you want to hear from your other dentist or make an educated and informed decision.”

Health professionals are adapting to a harsh reality in which consumers rate them on sites like Yelp, Vitals and RateMDs much as they do restaurants, hotels and spas. The vast majority of reviews are positive. But in trying to respond to negative ones, some providers appear to be violating the Health Insurance Portability and Accountability Act, the federal patient privacy law known as HIPAA. The law forbids them from disclosing any patient health information without permission.

Yelp has given ProPublica unprecedented access to its trove of public reviews — more than 1.7 million in all — allowing us to search them by keyword. Using a tool developed by the Department of Computer Science and Engineering at the NYU Tandon School of Engineering, we identified more than 3,500 one-star reviews (the lowest) in which patients mention privacy or HIPAA. In dozens of instances, responses to complaints about medical care turned into disputes over patient privacy.

The patients affected say they’ve been doubly injured — first by poor service or care and then by the disclosure of information they considered private.

The shock of exposure can be effective, prompting patients to back off.

“I posted a negative review” on Yelp, a client of a California dentist wrote in 2013. “After that, she posted a response with details that included my personal dental information. … I removed my review to protect my medical privacy.”

The consumer complained to the Office for Civil Rights within the U.S. Department of Health and Human Services, which enforces HIPAA. The office warned the dentist about posting personal information in response to Yelp reviews. It is currently investigating a New York dentist for divulging personal information about a patient who complained about her care, according to a letter reviewed by ProPublica.

The office couldn’t say how many complaints it has received in this area because it doesn’t track complaints this way. ProPublica has previously reported about the agency’s historic inability to analyze its complaints and identify repeat HIPAA violators.

Deven McGraw, the office’s deputy director of health information privacy, said health professionals responding to online reviews can speak generally about the way they treat patients but must have permission to discuss individual cases. Just because patients have rated their health provider publicly doesn’t give their health provider permission to rate them in return.

“If the complaint is about poor patient care, they can come back and say, ‘I provide all of my patients with good patient care’ and ‘I’ve been reviewed in other contexts and have good reviews,’ ” McGraw said. But they can’t “take those accusations on individually by the patient.”

McGraw pointed to a 2013 case out of California in which a hospital was fined $275,000 for disclosing information about a patient to the media without permission, allegedly in retaliation for the patient complaining to the media about the hospital.

Yelp’s senior director of litigation, Aaron Schur, said most reviews of doctors and dentists aren’t about the actual health care delivered but rather their office wait, the front office staff, billing procedures or bedside manner. Many health providers are careful and appropriate in responding to online reviews, encouraging patients to contact them offline or apologizing for any perceived slights. Some don’t respond at all.

“There’s certainly ways to respond to reviews that don’t implicate HIPAA,” Schur said.

In 2012, University of Utah Health Care in Salt Lake City was the first hospital system in the country to post patient reviews and comments online. The system, which had to overcome doctors’ resistance to being rated, found positive comments far outnumbered negative ones.

“If you whitewash comments, if you only put those that are highly positive, the public is very savvy and will consider that to be only advertising,” said Thomas Miller, chief medical officer for the University of Utah Hospitals and Clinics.

Unlike Yelp, the University of Utah does not allow comments about a doctor’s medical competency and it does not allow physicians to respond to comments.

In discussing their battles over online reviews, patients said they’d turned to ratings sites for closure and in the hope that their experiences would help others seeking care. Their providers’ responses, however, left them with a lingering sense of lost trust.

Angela Grijalva brought her then 12-year-old daughter to Maximize Chiropractic in Sacramento, Calif., a couple years ago for an exam. In a one-star review on Yelp, Grijalva alleged that chiropractor Tim Nicholl led her daughter to “believe she had scoliosis and urgently needed x-rays, which could be performed at her next appointment. … My daughter cried all night and had a tough time concentrating at school.”

But it turned out her daughter did not have scoliosis, Grijalva wrote. She encouraged parents to stay away from the office.

Nicholl replied on Yelp, acknowledging that Grijalva’s daughter was a patient (a disclosure that is not allowed under HIPAA) and discussing the procedures he performed on her and her condition, though he said he could not disclose specifics of the diagnosis “due to privacy and patient confidentiality.”

“The next day you brought your daughter back in for a verbal review of the x-rays and I informed you that the x-rays had identified some issues, but the good news was that your daughter did not have scoliosis, great news!” he recounted. “I proceeded to adjust your daughter and the adjustment went very well, as did the entire appointment; you made no mention of a ‘misdiagnosis’ or any other concern.”

In an interview, Grijalva said Nicholl’s response “violated my daughter and her privacy.”

“I wouldn’t want another parent, another child to go through what my daughter went through: the panic, the stress, the fear,” she added.

Nicholl declined a request for comment. “It just doesn’t seem like this is worth my time,” he said. His practice has mixed reviews on Yelp, but more positive than negative.

A few years ago, Marisa Speed posted a review of North Valley Plastic Surgery in Phoenix after her then–3-year-old son received stitches there for a gash on his chin. “Half-way through the procedure, the doctor seemed flustered with my crying child. …,” she wrote. “At this point the doctor was more upset and he ended up throwing the instruments to the floor. I understand that dealing with kids requires extra effort, but if you don’t like to do it, don’t even welcome them.”

An employee named Chase replied on the business’s behalf: “This patient presented in an agitated and uncontrollable state. Despite our best efforts, this patient was screaming, crying, inconsolable, and a danger to both himself and to our staff. As any parent that has raised a young boy knows, they have the strength to cause harm.”

Speed and her husband complained to the Office for Civil Rights. “You may wish to remove any specific information about current or former patients from your Web-blog,” the Office for Civil Rights wrote in an October 2013 letter to the surgery center.

In an email, a representative of the surgery center declined to comment. “Everyone that was directly involved in the incident no longer works here. The nurse on this case left a year ago, the surgeon in the case retired last month, and the administrator left a few years ago,” he wrote.

Reviews of North Valley Plastic Surgery are mixed on Yelp.

Health providers have tried a host of ways to try to combat negative reviews. Some have sued their patients, attracting a torrent of attention but scoring few, if any, legal successes. Others have begged patients to remove their complaints.

Jeffrey Segal, a onetime critic of review sites, now says doctors need to embrace them. Beginning in 2007, Segal’s company, Medical Justice, crafted contracts that health providers could give to patients asking them to sign over the copyright to any reviews, which allowed providers to demand that negative ones be removed. But after a lawsuit, Medical Justice stopped recommending the contracts in 2011.

Segal said he has come to believe reviews are valuable and that providers should encourage patients who are satisfied to post positive reviews and should respond — carefully — to negative ones.

“For doctors who get bent out of shape to get rid of negative reviews, it’s a denominator problem,” he said. “If they only have three reviews and two are negative, the denominator is the problem. … If you can figure out a way to cultivate reviews from hundreds of patients rather than a few patients, the problem is solved.”

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FDA approves Bioventrix trial for Revivent TC heart failure device

BioVentrixBioventrix said today it won FDA investigational device exemption approval to initiate a pivotal trial of its Revivent TC transcatheter ventricular enhancement system device designed for reshaping and restoring the left ventricle.

Revivent is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart. Instead, the transcatheter procedure enables placement of small titanium anchors along the heart’s outer surface and along one of the inside walls, according to Bioventrix. The anchors are then pulled toward each another in a way that excludes scarred and non-functioning portions of the heart wall.

“The Revivent TC system has recently demonstrated efficacy in clinical trials performed in the EU. This technology provides a less invasive means for LV scar reduction/exclusion in patients with prior myocardial infarction and LV dysfunction.  Restoration of LV morphologic and volume characteristics in a less invasive manner, compared with current surgical ventricular restoration, will ideally avail this technology and procedural concept to a larger patient population,” medical affairs veep Dr. Ryan Brown said in a prepared release.

The trial, which the company has titled Alive, is slated to enroll 120 patients at 20 sites across the U.S. with a planned primary endpoint analysis at 1 year. Endpoints include improvements in ejection fraction, volume reduction, quality of life, New York Heart Association Class, 6-minute walk test and rehospitalization rate.

“Heart failure continues to be an epidemic and the Bioventrix technology fills a critical need here in the U.S. for ischemic patients. The current therapy, surgical ventricular reconstruction, is effective yet it is highly invasive and limited in terms of patients being able to withstand the procedure.  This IDE approval provides another treatment option that physicians can consider when exploring the best therapy solution for heart failure patients,” trial principal investigator Dr. Andrew Wechsler said in prepared remarks.

Earlier this month, Bio Ventrix said it successfully implanted its micro-anchor Revivent device into a 64-year-old female patient suffering from heart failure symptoms following a heart attack.

The 1st-in-human test follows a similar successful procedure in a pre-clinical model last December. Researchers used Revivent in what it refers to as LIVE (less-invasive ventricular enhancement) a transcatheter-based procedure designed to reshape and reduce the size of the wall of the heart’s left ventricle.

The company, which is based in San Ramon, Calif., and Vilnius, raised $14 million last December in a new round of equity funding involving 64 anonymous investors.

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Arch Therapeutics raises $3.4m to support novel blood control dev

Arch TherapeuticsArch Therapeutics (OTC:ARTH) said last week it raised $3.4 million through the private placement of the company’s securities with a group of investors.

The Framingham, Mass.-based company said it floated approximately 9.5 million shares at 36¢ per share in the placement round.

Each unit offered in the round includes 1 share of common stock and 1 Series E warrant to purchase 3/4 of a share of common stock at 44¢ per share for up to 5 years. The company said it expects to offer approximately 7.1 million Series E warrants along with the 9.5 million shares, according to a press release.

Maxim Group acted as the placement agent for the transaction, the company said.

In March, Arch Therapeutics said it launched a European safety-and-efficacy study of its AC5 surgical hemostat in bleeding wounds incurred during dermatology procedures.

Arch, which won approval for the randomized, controlled, single-blind study last December, said the 46-patient trial will include a 10-subject arm who are taking blood thinners. Each patient will have at least 2 lesions removed, with 1 wound treated using the AC5 hemostat and the 2nd with a control treatment. Arch bills AC5 as designed to stop bleeding in seconds, rather than minutes, and conform to wound geometries while staying transparent, without the stickiness of other hemostats that makes them a challenge to use in laparoscopic procedures.

Endpoints in the trial include time to hemostasis and product-related adverse effects at 30 days, with follow-up at 7 days and 30 days post-procedure. Data from the trial are slated to drop within 2 quarters, Arch said.

The endpoints include product related adverse effects and time to hemostasis. Follow-up assessments of patients are planned for seven and 30 days following the procedure. As previously stated, data are projected to be available within two quarters of the start of the trial.

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MassDevice.com +5 | The top 5 medtech stories for May 31, 2016

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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5. Cordis recalls Precise Pro RX carotid stent over separation issues

MassDevice.com news

Cardinal Health subsidiary Cordis recently revealed a voluntary recall of its Precise Pro RX nitinol carotid stent system based on issues with shaft separation during stent deployment.

The issue was discovered after the company received complaints about separation difficulties with the stent, which is indicated for use in patients with stenotic lesions of the carotid artery, and investigated the issue independently. Read more


4. SV Life Sciences’ 6th fund pulls in $274m

MassDevice.com news

SV Life Sciences said it raised $274 million of the $400 million it hopes to put into its 6th fund for investing in healthcare companies.

The Boston-based venture capital shop said in a regulatory filing that 24 unnamed investors participated in the round, which began in May 2015. Read more


3. Intuitive Surgical warns on embolism risk with da Vinci Xi in heart procedures

MassDevice.com news

Intuitive Surgical today warned of the risk that small particulates could be introduced inside the heart during intra-cardiac procedures using its da Vinci Xi device.

Sunnyvale, Calif.-based Intuitive said it hasn’t received any reports of injuries related to the high-density polyethylene particles it turned up during quality inspections of its 5mm-8mm universal seal or the 12mm & stapler universal seal used with the da Vinci Xi. Intuitive said the particulate was found in the insufflation stopcocks used with the seals. Read more


2. Diabetes: FDA panel to mull expanded indication for Dexcom G5 continuous glucose monitor

MassDevice.com news

The FDA said it’s planning to convene an advisory panel in July to consider expanding the indication for the G5 mobile continuous glucose monitor made by Dexcom.

The Center for Devices & Radiological Health’s chemistry & toxicology panel is slated to meet July 21 to recommend whether the intended use for the Dexcom G5 should be changed so that diabetics can use it to replace finger-stick blood glucose monitoring; the G5 device measures glucose using the interstitial fluid surrounding cells just under the skin. Read more


1. Medtronic’s Q4, 2016 numbers top Wall Street

MassDevice.com news

Medtronic today reported fiscal year-end results that topped both sales and earnings estimates on Wall Street, sending share prices up a tick this morning.

The world’s largest pure-play medical device maker said it swung to Q4 black for the 3 months ended April 29, after putting up a -$1 million loss during the same period last year. Profits for Q4 2016 were $1.10 billion, or 78¢ per share, on sales growth of 3.6% to $7.57 billion compared with Q4 2015. Read more

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Pixium wins UK nod for Iris II ‘bionic eye’ trial

Pixium VisionFrench retinal implant maker Pixium Vision said today it won U.K. Medicines & Healthcare products Regulatory Agency approval to initiate a clinical trial of its Iris II bionic vision system designed to restore sight to patients with retinitis pigmentosa.

The Iris system is comprised of a retinal implant and a pair of camera-mounted glasses connected to a “pocket computer.” The computer processes images captured by the glasses and transmits the data into a signal that’s transferred back and projected onto the intraocular implant, where it stimulates the optic nerve and generates images that the brain learns to interpret as visual signals.

“We are excited to participate in the clinical trial of Iris II and be the first site in the UK. Patients with RP can now benefit from a new choice of retinal implant that may potentially further improve visual outcomes. This new clinical trial is key for ophthalmic reference centres like Moorfields to evaluate the latest technologies, and provide patients with a retinal implant that is differentiated and allows retinal implant exchanges in the future. We are delighted to work with Pixium Vision to develop solutions for retinal dystrophies like RP and age-related macular degeneration,” study principal investigator Mahi Muqit of the U.K.’s Moorfields Eye Hospital said in a press release.

The French company said that it initiated the CE Mark approval process in December based on previous Iris clinical trials, and expects to commercialize the device in the 2nd half of 2016, if approval is achieved.

“The UK approval for the clinical study further reinforces our confidence in the IRISII platform, our first innovative bionic vision system. Currently as the only company developing an epi-retinal system for RP patients and a sub-retinal wireless photovoltaic implant for AMD patients, we are delighted to initiate this clinical partnership with the world renowned Moorfields Eye Hospital in the UK,” CEO Khalid Ishaque said in a prepared statement.

In February, Pixium announced the 1st implantation and successful activation of its Iris II epi-retinal implant designed for patients with vision loss as a result of retinitis pigmentosa.

The 1st implant took place in January and was performed by Michel Weber of France’s University Hospital of Nantes, the company said. Up to 10 patients are slated to be included in a clinical trial of the device, according to Pixium Vision.

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EQT deals Atos Medical to PE shop for $946m

Atos Medical(Reuters) — Swedish buyout house EQT said yesterday that it sold its medical device business, Atos Medical, to private equity firm PAI Europe, with sources valuing the deal at about €850 million ($946 million).

PAI Europe won the bid for Atos, which makes voice implants, EQT said in a statement, but the 2 parties agreed not to disclose the transaction value.

People familiar with the matter told Reuters that the Swedish company had been valued at about €850 million during the negotiations.

Last year, Atos reported 30% growth in revenue to 1 billion Swedish crowns ($120,000) and 2016 earnings before interest, tax, depreciation and amortization (EBITDA) are expected to come in at €60 million, against about €40 million last year.

($1 = 8.3420 Swedish crowns)

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Spine Wave closes $11m round to support portfolio expansion

Spine WaveSpine Wave said today it closed a $11 million round of new financing to support “the largest product portfolio expansion in the company’s history.”

The round was led by existing investors New Enterprise Associates and Acadia Woods, and joined by Compass Global Fund, Industry Ventures, Collinson, Howe and Lennox, California Technology Partners and MB Ventures, the Shelton, Conn.-based company said.

“This is a very exciting time for Spine Wave as we are rapidly evolving and expanding our product portfolio. In the coming months we will be introducing a series of highly differentiated technologies that leverage our proven expertise with expandable and other less-invasive solutions. We appreciate the ongoing support from NEA and from all of our investors. This financing positions the Company to fully capitalize on the most significant product portfolio expansion undertaken by Spine Wave since its inception,” CEO Mark LoGuidice said in a press release.

Funds for the debt financing round came from 30 investors, according to an SEC filing, though the filing only showed $4.4 million raised so far for the company.

Spine Wave said it has several new products, including next-gen expandable technologies, currently in a limited market release, with plans for a full commercial launch of 7 new products over the next 12 to 18 months.

“Spine Wave’s product offering is undergoing a dramatic transformation, with the introduction of several exciting new products that were generated through a combination of both strategic acquisitions as well as internal development. The company’s portfolio has broadened significantly beyond its large franchise focused on the StaXx XD expandable device and the coming year will see a significant acceleration of this effort. This financing will support Spine Wave’s aggressive launch of a wide range of differentiated spinal implants which will make the company a player in the majority of the large spine market segments,” board member Ryan Drant said in a prepared statement.

in February, Spine Wave said it is licensing the True Position pivoting spacer system technology from Atlas Spine.

The center pivot point technology from the newly licensed True Position spacer allows for more easy and accurate position of interbody spacers, which Spine Wave said will be useful for surgeons implanting “crescent” type devices in a posterior-approach procedure.

Spine Wave said the true position pivoting spacer system is designed so it can be implanted using minimally invasive techniques. The system includes the True Position XL system designed to provide posterior implants with an implant “footprint”.

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Medtronic opens APac HQ, service & repair center in Singapore

MedtronicMedtronic (NYSE:MDT) said today it opened a new Asia Pacific regional headquarters, which includes a service and repair center, in Singapore.

The Fridley, Minn.-based company said that along with the opening it inked a deal with SingHealth to develop a “Centre of Excellence” for treating diabetes across Southeast Asia.

“The opening of Medtronic regional headquarters in Singapore marks an important milestone in our growing presence in Asia Pacific. We continue to leverage our regional expertise and partnerships to reach more patients, in more places and through more ways via collaborating with new partners. The rising prevalence of diabetes in the region is driving up healthcare costs and adversely impacting the lives of millions of people. There is tremendous opportunity to improve treatments across the diabetes care continuum via meaningful innovation and collaboration. We are excited to work with SingHealth as our strategic partner to explore new approaches in solving challenges associated with diabetes care,” APac prez Bob White said in a press release.

The diabetes center aims to advance treatment of diabetes in the region, increase education and facilitate the adoption of new diabetes tech, Medtronic said.

“There is an urgent need to tackle the diabetes challenge globally to reduce the burden of the disease. This will require active collaboration between different stakeholders to address the needs of our patients. We see this partnership with Medtronic as an exciting way forward in bringing better diabetes care to our patients, particularly through the adoption of innovative technology,” SingHealth Duke-NUS Diabetes Centre head Dr. Bee Yong Mong said in a prepared statement.

Last week, Medtronic said it inked a collaborative deal with Qualcomm (NASDAQ: QCOM) subsidiary Qualcomm Life to develop next-gen continuous glucose monitoring systems.

The companies will initially focus on single-use CGM system designed for physicians who manage type 2 diabetes patients, Medtronic said. Qualcomm Life will aid in the technology development for the wireless, single-use device, as well as a new sensor to provide near-real time and retrospective glucose data, the company said.

The under-development CGM device will feature it Qualcomm Life’s 2net Design platform used to design connected medical devices, including drug delivery and diagnostic devices designed for condition specific therapies, Medtronic said.

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Cordis recalls Precise Pro RX carotid stent over separation issues

Cardinal Health's CordisCardinal Health (NYSE:CAH) subsidiary Cordis recently revealed a voluntary recall of its Precise Pro RX nitinol carotid stent system based on issues with shaft separation during stent deployment.

The issue was discovered after the company received complaints about separation difficulties with the stent, which is indicated for use in patients with stenotic lesions of the carotid artery, and investigated the issue independently.

Cordis said it discovered that affected lots of the Precise stent system had an “increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment,” according to its urgent safety recall notice.

No patient injuries have been reported related to the shaft separation issue, Cordis said. The company warned that the malfunction could cause intra-procedural delay for the patient while a replacement device is prepped.

Cordis also warned against the possibility of vessel damage which would require unplanned percutaneous surgical intervention, and the possibility of transient ischemic attack or stroke in severe cases.

The company said it is recalling products manufactured between April 27, 2015 and November 22, 2015, which includes 16 catalog numbers and 179 lots.

Cordis advised affected users to identify affected units and return them.  The company said it notified all appropriate regulatory bodies of the recall and separation issues.

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Neovasc wins round in patent battle with Edwards Lifesciences subsidiary CardiAQ Valve

Edwards, CardiAQ, NeovascNeovasc (NSDQ:NVCN) last week won a round in its patent battle with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies that’s already got it on the hook for some $70 million in damages.

A federal jury in Massachusetts found earlier this month that Neovasc stole trade secrets and breached a non-disclosure agreement with CardiAQ in developing the Tiara transcatheter mitral valve replacement. Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014.

A Bay State federal judge tossed a claim alleging that Neovasc violated Massachusetts laws against unfair competition and unfair or deceptive practices. Judge Allison Burroughs ruled May 27 that because most of the wrongdoing took place in Canada, not Massachusetts as required by the statute.

“At trial, CardiAQ did not identify any actionable conduct by Neovasc that occurred inMassachusetts. Throughout the relevant time period, Neovasc was headquartered in Canada. Neovasc received CardiAQ’s confidential information and trade secrets while in Canada, worked on CardiAQ’s prototypes from its facility in Canada, and developed its competing device in Canada,” Burroughs wrote. “Further, because CardiAQ moved to California in February 2010, it is not even clear that CardiAQ experienced all of the harm within Massachusetts.”

Burroughs also said she would require both parties to submit briefs on a remaining correction of inventorship claim, after a hearing on CardiAQ’s bid for an injunction slated for June 3, and plans to decide the inventorship claim and final judgment after that.

Filings show a partnership gone sour

According to court documents, Neovasc approached CardiAQ Valve in June 2009 and offered to help it develop a TMVI device. The companies signed an NDA and worked together on the replacement heart valve until February 2010.

But in mid-2009, CardiAQ valve alleged, Neovasc breached the NDA by using the CardiAQ Valve technology as the basis for the Tiara device, including in patent filings.

The jury found Neovasc guilty May 19 of breach of contract, but did not award any damages for that claim, according to the documents. But the panel found that Neovasc misappropriated 3 of the 6 trade secrets claimed in the suit, awarding $70 million in damages to CardiAQ.

The jury also found that Neovasc used unfair or deceptive trade practices and that CardiAQ Valve co-founder, president & COO Brent Ratz (now an R&D VP for Edwards’ TMVR program) and co-founder Dr. Arshad Quadri (the “AQ” in CardiAQ) contributed to the conception of the CardiAQ Valve patent.

“Through many years of dedicated work with Dr. Quadri, we were able to develop an extensive base of knowledge, make important advancements and create the CardiAQ transcatheter mitral valve to help patients in need who are not well-served by therapies available today,” Ratz said at the time. “We are proud of this foundational work and grateful that the jury recognized these contributions to the developing field of transcatheter mitral valve replacement.”

“Regrettably, the jury trial phase of this lawsuit was not resolved to our satisfaction. We will be exploring our options regarding post-trial motions in the trial court and, potentially, the appellate process,” Neovasc CEO Alexei Marko said after the jury verdict. “As we have throughout this process, we will remain diligent in our company’s purpose to advance our cardiovascular products to improve patient care by addressing two significant unmet structural heart diseases, mitral regurgitation and refractory angina.”

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Intuitive Surgical warns on embolism risk with da Vinci Xi in heart procedures

Intuitive SurgicalIntuitive Surgical (NSDQ:ISRG) today warned of the risk that small particulates could be introduced inside the heart during intra-cardiac procedures using its da Vinci Xi device.

Sunnyvale, Calif.-based Intuitive said it hasn’t received any reports of injuries related to the high-density polyethylene particles it turned up during quality inspections of its 5mm-8mm universal seal or the 12mm & stapler universal seal used with the da Vinci Xi. Intuitive said the particulate was found in the insufflation stopcocks used with the seals.

“The particulate has the potential to be introduced into the cannula lumen when insufflation is connected. Although there have been no injuries identified related to this issue, we are initiating this warning for use in intra-cardiac procedures due to risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart,” the company said. “During abdomino-pelvic and thoracic surgery, if the potential particulate is undetected and unintentionally left behind, health risk is minimal due to the bio-inert properties of the high density polyethylene (HDPE) particulate, its small size and the benign particulate geometry.”

The particulates are less than ⅛ in. long and do not have sharp edges, Intuitive said, noting that HDPE has a nearly 80-year history of use as an implant material. It has no iron content and is therefore safe for MRI scans, the company said.

Intuitive said customers should not use the da Vinci Xi 5mm-8mm universal seal or the 12mm & stapler universal seal during intra-cardiac procedures. An angiocatheter or Veress needle could be used instead, the company said.

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SV Life Sciences’ 6th fund pulls in $274m

SV Life SciencesSV Life Sciences said it raised $274 million of the $400 million it hopes to put into its 6th fund for investing in healthcare companies.

The Boston-based venture capital shop said in a regulatory filing that 24 unnamed investors participated in the round, which began in May 2015.

SV Life Sciences, which has some $1.9 billion under management, invests in medical device, biotech and healthcare services companies.

Its medtech portfolio includes AcuFocusCardioFocus, CardioKinetix, Direct Flow Medical, Insulet (NSDQ:PODD), ReShape MedicalTransEnterix (NYSE:TRXC) and Ximedica.

The VC firm raised a $523 million fund back in 2010.

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Diabetes: FDA panel to mull expanded indication for Dexcom G5 continuous glucose monitor

Dexcom

The FDA said it’s planning to convene an advisory panel in July to consider expanding the indication for the G5 mobile continuous glucose monitor made by  (NSDQ:DXCM).

The Center for Devices & Radiological Health’s chemistry & toxicology panel is slated to meet July 21 to recommend whether the intended use for the Dexcom G5 should be changed so that diabetics can use it to replace finger-stick blood glucose monitoring; the G5 device measures glucose using the interstitial fluid surrounding cells just under the skin.

Changing the device’s intended use would mean patients could make treatment decision based on the G5’s interstitial glucose readings, rather than merely for tracking them and predicting trends.

The FDA’s August 2015 approval for the Dexcom G5 came months ahead of expectations; the device won CE Mark approval in the European Union less than a month later. Last March Dexcom said it made the G5 compatible with Apple’s (NSDQ:AAPL) Apple Watch, but warned in April of possible alarm and alert malfunctions with the G5 and 1 of its predecessors, the G4 Platinum.

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Medtronic’s Q4, 2016 numbers top Wall Street

MedtronicMedtronic (NYSE:MDT) today reported fiscal year-end results that topped both sales and earnings estimates on Wall Street, sending share prices up a tick this morning.

The world’s largest pure-play medical device maker said it swung to Q4 black for the 3 months ended April 29, after putting up a -$1 million loss during the same period last year. Profits for Q4 2016 were $1.10 billion, or 78¢ per share, on sales growth of 3.6% to $7.57 billion compared with Q4 2015.

Adjusted to exclude 1-time items, earnings per share were 10¢ ahead of Wall Street at $1.37 for the quarter; analysts were also looking for Q4 sales of $7.48 billion.

Full-year profits surged 32.3% to $3.54 billion, or $2.48 per share, on sales growth of 42.3% compared with the last fiscal year, to $28.83 billion. Adjusted EPS were $4.84, 47¢ ahead of analysts’ consensus estimate, which put annual sales at $28.72 billion.

“Our organization once again successfully delivered strong, balanced revenue growth across our groups and geographic regions – growing above the market and exceeding our revenue growth projections,” chairman & CEO Omar Ishrak said in prepared remarks. “This quarter caps a transformative year for Medtronic, our 1st full year after closing the largest-ever medtech acquisition. I am pleased with the execution and focus of our teams around the world who delivered sustained revenue growth and exceeded our Covidien cost synergy commitments.”

Medtronic said it expects adjusted EPS of $4.60 to $4.70, or growth of 12% to 16% on a constant-currency basis, for fiscal 2017. Sales growth is pegged at the upper half of the mid-single digits, or 5% to 6% on a constant-currency basis.

“As we enter our new fiscal year, we look forward to delivering on our robust pipeline of products and services, expanding our global reach to serve more patients, and partnering with others around the world to develop new value-based business models,” Ishrak said. “We believe that Medtronic can play a meaningful leadership role with others in healthcare that can lead to better outcomes for patients, while improving overall healthcare system performance.”

MDT shares ticked up 0.7% to $82.24 apiece this morning, after closing up 0.6% May 27 at $81.67 per share.

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MDSAP Update: As pilot winds down, manufacturer buy-in still lacking

Emergo GroupBy Michael Dun, Emergo Group

The pilot for the international Medical Device Single Audit Program (MDSAP) is set to end in December 2016, but challenges including low manufacturer participation levels and lack of coordination among some regulators must still be addressed before full-blown implementation of the program can occur.

In this first of a two-part blog post, we’ll provide an overview and brief background on MDSAP. Our follow-up post will discuss the program’s current status, as well as ongoing challenges MDSAP proponents must address.

With the management committee of the International Medical Device Regulators Forum (IMDRF) chaired by Brazil’s National Health Surveillance Authority (ANVISA) in 2016, the most recent meeting of the committee was held from 8 to 10 March 2016 in Brasília.

Among the topics tabled by the committee was the Medical Device Single Audit Program (MDSAP), specifically an update on this pilot program and an expression of continued support for this program by the committee. Minor changes were also presented for IMDRF/MDSAP WG/N3:FINAL (2016) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition in order to bring in alignment with the requirements of ISO 17021:2015 Conformity Assessment – Requirements for Bodies Providing Audit and Certification of Management Systems – Part 1:Requirements.

A brief history and pilot objectives/criterion

In an effort to address the growing burden on government agencies for resources necessary to ensure continued medical device and IVD manufacturer compliance with quality system regulations and standards, at its first meeting in Singapore (2012), the IMDRF established a work group to establish a single, global audit program known as MDSAP as a substitute for regulatory authority (RA) inspections. The idea being that qualified auditing organizations (AOs) could prepare audit reports accepted by the IMDRF participating RAs  (ANVISA, the US Food and Drug Administration, Health Canada, Japan’s Pharmaceutical and Medical Devices Agency and the Australian Therapeutic Goods Administration) as evidence of compliance.

The IMDRF work group spent the next years developing the supporting requirements for this program, including the establishment of requirements for AOs for RAs, including the competence and training requirements for auditors used by such organizations.

The pilot was started on 1 January, 2014 and was originally slated to finish on 31 December, 2016. AOs selected to participate in this pilot were the following thirteen organizations within the Canadian Medical Device Conformity Assessment System (CMDCAS):

  • BSI Group America Inc.
  • TÜV SÜD America Inc.
  • SAI Global Cert. Services PTY Ltd.
  • LNE G-MED
  • TÜV USA Inc.
  • Intertek Testing Services NA Inc.
  • UL, LLC
  • DQS MED GmbH
  • NSAI
  • TÜV Rheinland of NA Inc.
  • DEKRA Certification B.V.
  • SGS UK Ltd.
  • LRQA Inc.

Furthermore, both objectives and acceptance criterion (proof of concept criterion, or PoCC) were established by the IMDRF work group in order to track the performance of the pilot. Details of these objectives and criterion include:

OBJECTIVES

(1) The MDSAP recognition of CMDCAS auditing organizations.

a. Application review and Head Office Assessments:

3-5 AOs by May 2014, December 2014 and May 2015, and any remainder of the 13 CMDCAS AOs by December 2015

b. Witness Audits for each of the respective 3-5 AOs within 6 months of their Head Office Audit

c. Completion of several Surveillance Assessments of AOs prior to the completion of the Pilot

d. Recognition of an AO will occur after successful application review and completion at a minimum of one (1) successful certification assessment and at a minimum one (1) successful assessment by the MDSAP Regulatory Authority(ies) during a witness audit of the AO auditing a medical device manufacturer(s) using the MDSAP audit process and reporting requirements.

(2) The analysis and evaluation of the results of the implementation of MDSAP program requirements and processes to confirm “proof-of-concept”.

(3) The identification and correction of existing and potential weaknesses within the MDSAP program based on study findings.

(4) Enable a fully operational program no later than 2016.

PROOF OF CONCEPT CRITERION (PoCC)

PoCC No. Performance Indicator Targets Performance Measurement Metric
1 Whether the format and content of audit and nonconformity reports comply with prescribed requirements > 70% of the sampled and evaluated reports comply. By a comparison of an evaluation of reports with the requirements of P0019 and the NC Grading & Exchange Form # of satisfactory reports / # reports evaluated
2 Whether the evidence provided in audit and nonconformity reports, for common QMS requirements, supports the findings and NC grades > 80% consistency in the conclusions of the regulators By a comparison of the evaluations of audit evidence and NC grading performed by different RA on the same sampled reports # consistent reports among regulators / # reports on which comparison was performed
3 Whether audit and nonconformity reports would substantiate regulatory decisions > 80% of reports evaluated would substantiate regulatory decisions By evaluation of the evidence in audit and nonconformity reports for their capability to substantiate regulatory decisions # reports suitable for regulatory decisions / # reports evaluated by RAs
4 Whether the audit model and task sequence appropriately assesses QMS and regulatory requirements < 5% of audit model tasks requires a correction or corrective action. By RA assessors observing the application of the audit tasks, as well as feedback from AOs # of audit tasks requiring corrections / # of audit model tasks
5 Whether the assessment model and task sequence appropriately assesses MDSAP requirements < 25% of assessment model tasks require a correction or corrective action By RA self-evaluation and AO’s feedback about the application of the assessment tasks at HO, CL assessments and at witnessed audits # of assessment tasks for which a NC is raised / # of assessment model tasks
6 Whether time provided in the audit duration model is suitable for evaluating and recording evidence of conformity / nonconformity with requirements The duration for an MDSAP audit is ≥ 100% and ≤ 120% of the calculated duration By observing the duration of witnessed audits and, at the conclusion, deducting the duration calculated by the AO to account for parallel activities Duration of witnessed audit / calculated MDSAP audit duration
7 Whether a sufficient number of candidate AOs are recognised > 75% of Health Canada MD Licences could be assessed by candidate AOs By determining the # of MD Licenses supported by a CMDCAS/ MDSAP QMS cert from a Registrar that is a candidate AO # of MDL supported by CMDCAS / MDSAP AO cert / # of MDLs
8 Whether a sufficient number of manufacturers participate in MDSAP > 10% of a candidates AO’s CMDCAS clients By determining the number of medical device manufacturers (MDMs) that have applied to participate # of MDMs that have applied to participate / # of CMDCAS clients of all candidate AOs

 

Michael Dun is Senior QA/RA Consultant in Emergo’s office in Brazil.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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divendres, 27 de maig del 2016

EndoGastric Solutions launches EsophyX Z device designed to treat GERD

EndoGastric SolutionsEndoGastric Solutions said today it launched its EsophyX Z device designed for treating gastroesophageal reflux disease, and that the device was used in its 1st treatment procedure.

The 1st procedure was performed during a transoral incisionless fundoplication procedure at Cali.’s U.C. Irvine Health by Dr. Kenneth Chang, the Redmond, Wash.-based company said.

“There are certain GERD patients who don’t respond effectively to medical management with proton pump inhibitors. Long-term data continue to demonstrate the positive impact the TIF procedure for reflux has in controlling chronic, troublesome GERD symptoms,” Dr. Chang said in a prepared statement.

The EsophyX Z device is designed for the reconstruction of the gastroesophageal valve through a partial fundoplication procedure, performed transorally.

“We are excited and honored to have Dr. Chang perform the first TIF procedure using the new EsophyX Z device via the TIF 2.0 procedure to treat a chronic GERD patient. This marks another notable milestone for EGS as we continue to address the significant problem of GERD and focus on filling the treatment gap between medication and more invasive surgery,” CEO Skip Baldino said in a press release.

The company said it is entering a limited U.S. release with a full commercialization of the product planned this summer.

In December, EndoGastric Solutions said it raised $50 million in a new round of financing for its EsophyX acid reflux treatment device.

The round was led by CRG and joined by existing EGS investors Advanced Technology Ventures, Canaan Partners, Chicago Growth Partners, Foundation Medical Partners and Radius Ventures, the Redmond, Wash.-based company said

Funds from the round will be used to enhance commercialization and continue R&D of the company’s next generation products for use in its proprietary TIF procedure.

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MassDevice.com +5 | The top 5 medtech stories for May 27, 2016

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. Nephros inks distro deal with CS Medical

MassDevice.com news

Nephros said today it signed a distribution agreement with CS Medical to distribute Nephros’ DSU-H ultrafilter as an option with CS Medical’s TD 100 automated trans-esophageal echocardiogram probe disinfector.

The DSU-H filter from Nephros has FDA 510(k) clearance and is designed to provide ultrapure water as an aid in infection prevention and control, CS Medical said. Read more


4. FDA slaps Class 1 label on Medtronic Capnostream battery pack recall

MassDevice.com news

The FDA today labeled Medtronic‘s voluntary recall of battery packs used with its Covidien Oridion labeled Capnostream 20 and 20p patient monitors as Class I.

The devices are being recalled due to a defect causing an increased risk of thermal damage in the packs. Read more


3. Senate bill looks to streamline CMS pathway for “breakthrough” devices

MassDevice.com news

The U.S. Senate has introduced a bill to expedite Centers for Medicare and Medicaid Services decision making for new medical devices.

The bill, titled the “Ensuring Patient Access to Critical Breakthrough Product Act” will help “bridge a gap” between the FDA and CMS and “improve patient access to breakthrough medical technologies,” according to a new report from medical device industry group Advamed. Read more


2. Novartis pharma head Epstein steps away, most recent in string of top-level turnovers

MassDevice.com news

Novartis is facing an upheaval in its top management, seeing 7 departures over the last 5 months as shares fell 25% since last July. Read more

 


1. Fighting opioid addiction with medical devices: FDA approves new implant

MassDevice.com news

The FDA today cleared a new opioid-addiction fighting implant from Braeburn Pharmaceuticals, the 1st of its kind to win a nod from the federal watchdog.

The matchstick-sized Probuphine implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies. Read more

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Report: Insurer accuses Intuitive of hiding over 700 injury claims

Intuitive SurgicalTwo insurance companies are claiming that Intuitive Surgical (NSDQ:ISRG) failed to reveal more than 700 injury claims when it applied for liability coverage, according to a new report from Bloomberg.

Intuitive Surgical, maker of the prominent da Vinci surgical robotic platform, says the claims are false, and is accusing Illinois Union Insurance Co. and Navigators Specialty Insurance Co. of “acting deceitfully and breaking their contracts,” according to the report.

The dispute could end up leaving Intuitive Surgical self-insured for a one-year period if a federal judge decides in favor of the insurers, who provide $25 million in coverage to Intuitive.

Illinois Union claims Intuitive disclosed just 24 claims and failed to reveal 734 more when it applied for coverage in 2013. The insurer went on to call the move from Intuitive “a massive concealment of claims from an insurer, potentially the most egregious in history,” according to the report.

The insurer says it would have withdrawn its liability coverage offer if it had known that Intuitive entered into 100s of so-called tolling agreements, Bloomberg reports.

Navigators and Illinois Union are slated to go before U.S. District Judge Jon Tigar in San Francisco next Thursday as they seek a rescission request without a trial.

Intuitive argues that a rescission of the 2013 policy would be premature due to a number of factual issues in dispute, Bloomberg reports. The company is arguing that the policy application asked only about incidents “likely to result in a claim.”

The robotic surgery company countersued both insurers in October, Bloomberg said, after they refused to cover losses related to da Vinci claims.

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Thermo Fisher picks up electron microscopy firm FEI for $4.2B

Thermo Fisher ScientificThermo Fisher (NYSE:TMO) said today it bought electron microscopy developer FEI Company for $4.2 billion, through the acquisition of stock at $107.5 per share in cash.

FEI designs, manufactures and supports high-performance electron microscopy workflows, Thermo Fisher said. The company has more than 3,000 employees worldwide and reported revenues of $930 million last year.

“We are pleased to reach this agreement with Thermo Fisher, which offers a number of important benefits to FEI shareholders, customers and employees. Our shareholders will see substantial and immediate value through the terms of this transaction. Our customers will benefit from the shared commitment Thermo Fisher and FEI have to innovation and customer service. And our employees will see new opportunities as our development and market expansion plans accelerate by being part of Thermo Fisher, a large and growing company. Fundamentally, this transaction bolsters our already strong position in the marketplace and allows us to play an increasing role in enabling our customers to accelerate breakthrough discoveries, increase productivity and provide solutions to global challenges,” FEI CEO Don Kania said in a prepared statement.

The news came 2 months after Thermo Fisher bought gene-sequencing products maker Affymetrix Inc to boost its product offerings with smaller, complementary acquisitions.

Thermo Fisher told analysts last week that it expected to deploy about $12 billion of capital over the next three years for these deals, which could drive a $3 billion upside in revenue, Cowen and Co analysts wrote in a note.

“The addition of FEI’s leading electron microscopy platform is an outstanding strategic fit with our company and will create significant value for our customers and our shareholders. In life sciences, there is growing adoption of electron microscopy to study the structure of proteins. The technologies we gain with FEI will complement our mass spectrometry leadership, putting Thermo Fisher in the best position to capitalize on this important trend. As the unrivaled leader in life sciences, we will also be able to leverage our global scale and commercial reach to extend the use of FEI’s products within our large biopharma customer base. Finally, the transaction will be immediately accretive to our earnings and will create value for our shareholders through cost and revenue synergies,” Thermo Fisher CEO Marc Casper said in a press release.

Material from Reuters was used in this report.

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Fighting opioid addiction with medical devices: FDA approves new implant

Braeburn Pharmaceuticals ProbuphineThe FDA today cleared a new opioid-addiction fighting implant from Braeburn Pharmaceuticals, the 1st of its kind to win a nod from the federal watchdog.

The matchstick-sized Probuphine implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies.

“Patients and their doctors now have Probuphine as a new option for the 6-month treatment of opioid dependence. Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases – with evidence-based medicine. With 78 people in the U.S. dying each day from opioids, it’s important that patients have more treatments to choose from as no one option will work for everyone. Probuphine is the first of what we hope will be many new and innovative approaches to treating this disease. We are grateful to all of the patients, investigators and to NIDA for their help and dedication that has brought us to this point,” CEO Behshad Sheldon said in a press release.

Currently, opioid addiction is predominantly treated with one of 2 options: methadone and buprenorphine. Methadone is only dispensed at government-endorsed clinics in pill form, and while buprenorphine is available outside said clinics in pill or film form, both methods can be lost, forgotten, stolen or ignored.

The newly cleared Probuphine implant is designed to deliver a slow-release of buprenorphine continuously for up to 6 months, providing a low dose of 8 mg or less per day, Braeburn said.

The FDA cleared the slow-release implant for patients who are already stable on a low or moderate dose of oral buprenorphine, and indicated that the device should be used alongside counseling and other support systems.

“Probuphine represents a significant step forward in addressing the serious lack of new treatment options in the last 15 years. With strong support from the President and the Secretary of Health and Human Services this year to expand access to medication assisted treatment, addiction specialists like myself are more confident we will be able to get more patients the treatment they desperately need. Opioid dependence touches people from all walks of life, no matter their socioeconomic status, race or gender; the more we educate and innovate the better chance we have at reducing the prevalence of this terrible disease,” American Society of Addiction Medicine prez Dr. Kelly Clark said in prepared remarks.

Despite the backing from the FDA, some doctors are concerned that the implant may incentivize patients to rely solely on medication, and ignore the lifestyle changes they need to make.  The company will also likely face push-back from supporters of total-sobriety approaches at treating addiction.

Material from Reuters was used in this report.

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Nephros inks distro deal with CS Medical

Nephros, CS MedicalNephros (OTC:NEPH) said today it signed a distribution agreement with CS Medical to distribute Nephros’ DSU-H ultrafilter as an option with CS Medical’s TD 100 automated trans-esophageal echocardiogram probe disinfector.

The DSU-H filter from Nephros  has FDA 510(k) clearance and is designed to provide ultrapure water as an aid in infection prevention and control, CS Medical said.

“We are very excited about our partnership with CS Medical and our opportunity to help protect patients undergoing a TOE or TEE procedure. Our FDA cleared ultrafilters are able to meet the water purity needs of a number of specialized medical devices, including CS Medical’s market leading device, the TD 100,” Nephros N.A. sales director Shane Sullivan said in a press release.

CS Medical’s TD 100 automated TEE probe disinfector is designed to provide high-level disinfection for TEE probes to minimize potential for patient exposure to improperly reprocessed probes, the company said.

“Waterborne bacteria are an ever-growing challenge in healthcare facilities. The effects of these contaminates continue to cause an increasing rise in healthcare costs. Rinse water quality can affect a properly high-level disinfected medical device by introducing bacteria, viruses and endotoxins. CS Medical’s partnership with Nephros will provide a solution that provides ultrapure bacteriologically-filtered water during the rinse cycles of the TD 100 and help aid in the prevention of healthcare association infections. We are pleased to work with Nephros as CS Medical is committed to providing quality and reliable solutions for TEE ultrasound probe disinfection,” CS Medical prez Mark Leath said in a prepared statement.

In April, Nephros said it received a notice from the FDA closing out a warning letter the company received last May concerning issues with the manufacturing of a variety of its filtration systems.

The warning from the federal watchdog to River Edge, N.J.-based Nephros included warnings on a failure to document and evaluate potential suppliers and a failure to include required information in records and complaint investigations.

Nephros responded to the initial warning letter and received a response from the FDA in August outlining what corrective actions would be required.

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Senate bill looks to streamline CMS pathway for “breakthrough” devices

Capitol HillThe U.S. Senate has introduced a bill to expedite Centers for Medicare and Medicaid Services decision making for new medical devices.

The bill, titled the “Ensuring Patient Access to Critical Breakthrough Product Act” will help “bridge a gap” between the FDA and CMS and “improve patient access to breakthrough medical technologies,” according to a new report from medical device industry group Advamed.

“Currently, FDA has an established process to provide priority review to breakthrough technologies. We support reforms to that process in other pending legislation. However, there is no similar process at CMS to ensure patients have access to these devices and diagnostics in a timely manner. So, after FDA determines a breakthrough technology is safe and effective, sometimes it is years later before patients have access to it because of coverage and reimbursement delays at CMS. Medicare beneficiaries deserve better,” Advamed CEO Scott Whitaker said in a press release.

The bill was introduced by Sen. Dan Coats (R-Ind.), with the goal of establishing a program to accelerating transitional coverage and payment for new technologies that “offer breakthroughs for serious illnesses affecting medicare beneficiaries.”

“Researchers and entrepreneurs, including many in Indiana, regularly come up with groundbreaking new treatments for some of our worst illnesses, only to encounter government regulations that prevent many patients from receiving potentially life-saving care. This legislation would streamline the current process, allowing Medicare patients to receive new treatments while also ensuring proper safety and quality regulations are met,” Coats said in prepared remarks.

Through the legislation, new devices or diagnostics designated as a “breakthrough technology” and deemed safe and effective by the FDA would receive transitional coverage for 3 years by CMS.

Currently, FDA-cleared devices can receive expedited reviews but will still face up to 3 years to receive reimbursement and coverage from CMS, Coats said. The new bill would make “improvements to the outdated new technology add-on payment program” to remove barriers from patient adoption.

“Under the legislation, any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA would be provided immediate transitional coverage for three years by CMS. During the three-year period, the therapy would receive a predictable reimbursement, and CMS could specify what additional data, if any, would be needed to continue coverage after the three-year period,” Whitaker said in a prepared release. “These CMS reforms would both stimulate development of important new devices and diagnostics and assure more timely patient access to new treatment options. We look forward to working with members of Congress, CMS and other key stakeholders to move this legislation forward.”

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FDA slaps Class 1 label on Medtronic Capnostream battery pack recall

MedtronicThe FDA today labeled Medtronic‘s (NYSE:MDT) voluntary recall of battery packs used with its Covidien Oridion labeled Capnostream 20 and 20p patient monitors as Class I.

The devices are being recalled due to a defect causing an increased risk of thermal damage in the packs.

Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

Capnostream monitors are external devices used to assess respiratory status and identify changes in breathing, the Fridley, Minn.-based company said, and are used in both clinical and home settings.

The voluntary recall affects 9,817 battery packs with model numbers 016400 and 010520 manufactured by a contract manufacturer between April 2014 and February 2016. The packs were distributed nationwide, including Washington D.C., the FDA said.

In April, Medtronic initiated the voluntary recall and said it had received 7 reports of thermal damage out of the 9,817 battery packs affected by the field action, with 1 report involving a fire that resulted in smoke inhalation and minor burns, according to a press release.

The medtech giant sent a letter to customers with affected units along with a rework kit with full instructions for removal and disposal or recycling of the affected battery packs.

Medtronic said it recommended customers use the Capnostream monitors on AC power with the pack removed until a replacement battery is available.

Medtronic said it identified a manufacturing change conducted by the 3rd party contract manufacturer as the root cause and is manufacturing new batteries to meet the original specifications with a new contract manufacturers, which will be supplied to affected customers when available.

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Theranos sued over blood tests, in proposed class action

Theranos(Reuters) – Blood-testing company Theranos Inc was sued on Thursday, accused of endangering customer health through “massive failures” that misrepresented the accuracy and quality of its blood tests, according to court papers.

The proposed class action was brought in the U.S. District Court for the Northern District of California by the law firm Hagens Berman Sobol Shapiro LLP.

The complaint accuses the company of breach of contract, false advertising and consumer fraud, among other claims. It estimated that thousands of consumers could be eligible to join the lawsuit, citing Theranos’ claims that it had performed more than 6 million tests.

Officals at Theranos did not immediately respond to requests for comment.

Theranos last week notified U.S. federal health regulators that it voided results from its Edison blood-testing devices for two years, the Wall Street Journal reported, citing a person familiar with the matter.

The company informed the Centers for Medicare and Medicaid Services that it has issued tens of thousands of corrected blood-test reports to doctors and patients, nullifying some results and revising others, the Journal reported.

Theranos once touted its Edison device as a ground-breaking technology able to test blood from just a pinprick.

The complaint focuses on materials published by both Theranos and Walgreens Boots Alliance, which had agreed to offer blood testing from Theranos’ Edison device at dozens of wellness centers in Walgreen’s stores in Arizona and California.

CMS said in January that the blood-testing company’s practices violated several clinical-laboratory regulations, jeopardizing patient health and safety.

Theranos, which recently expanded its board to include Dr. Fabrizio Bonanni, a former Amgen Inc and Baxter International Inc executive, has been under investigation by several U.S. regulators in the recent past.

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Novartis pharma head Epstein steps away, most recent in string of top-level turnovers | Personnel Moves, May 27, 2015

Novartis pharma head Epstein steps away, most recent loss in string of top-level turnovers


novartis-epstein

Novartis (NYSE:NVS) is facing an upheaval in its top management, seeing 7 departures over the last 5 months as shares fell 25% since last July.

Last week, Novartis pharmaceuticals head David Epstein quit as his division was split up. Earlier in the month, U.S. country head Christi Shaw left the company as well.

In January, Alcon head Jeff George left as sales for the division continued to fall. Two months ago, medical affairs global head Ameet Nathwani jumped ship to rival Sanofi.

Chief ethics officer Eric Cornut is set to leave after 27 years with the company. Novartis Institute for Biomedical Research director Mark Fishman is retiring, as well as oncology research head William Sellars.

“After years of empire building … that’s what investors want. Clearly, the future of that company will be about specialized drugs, high-value drugs, so they can face up to what is the challenge in this industry: price deflation and price pressure,” Novartis investor and Jupiter Asset Management fund manager Cedric de Fonclare said in a press release.

Read more

The post Novartis pharma head Epstein steps away, most recent in string of top-level turnovers | Personnel Moves, May 27, 2015 appeared first on MassDevice.



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Agreement reached on Europe’s medical device and IVD regulations

Emergo GroupBy Ronald Boumans, Emergo Group

European regulators and lawmakers have agreed on long-awaited new regulations covering medical an in vitro diagnostic devices in one of the world’s largest markets.

On 25 May 2016 the European Parliament  and the European Council jointly announced that an agreement has been reached about the Regulations for Medical Devices and In-Vitro Diagnostics.

Emergo consultants in The Hague have learned that the First Reading Drafts will be published mid-June and the Regulations will be adopted in the autumn of 2016. There will be a three-year transition period for medical devices and a five-year transition for IVDs.

This means that manufacturers whose devices are CE Marked for sale in the European Union will have until autumn of 2019 to get ready for the medical device regulations and until autumn of 2021 for IVD regulations.

We will keep you informed once the drafts have been publicized. For in-depth analysis of the ongoing European regulatory overhaul, download our MDR whitepaper.

Previous Emergo blog coverage of European medical device and IVD regulatory changes can be found below:

Ronald Boumans is Senior Global Regulatory Consultant at Emergo’s office in The Netherlands, and a former senior inspector at the Dutch Healthcare Inspectorate.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The post Agreement reached on Europe’s medical device and IVD regulations appeared first on MassDevice.



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dijous, 26 de maig del 2016

MassDevice.com +5 | The top 5 medtech stories for May 26, 2016

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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5. Ortho Kinematics wins Health Canada nod for VMA system

MassDevice.com news

Ortho Kinematics said today it won Health Canada authorization for its Vertebral Motion Analysis spinal imaging system.

The VMA system from Austin, Texas-based Ortho Kinematics uses fluoroscopy to capture images of the spine in motion, is designed to displace traditional X-ray imaging as the primary method for identifying spinal dysfunction, the Austin, Texas-based company said. Read more


4. Israeli machine-learning radiology firm Zebra Medical Vision raises $12m

MassDevice.com news

Israeli machine-learning radiology firm Zebra Medical Vision said today it raised $12 million to support the development of imaging algorithms being designed for automatic reading and diagnosis of medical imaging data.

The round was led by InterMountain Healthcare, and joined by existing investors, Zebra Medical Vision said. As part of its investment, InterMountain Healthcare plans to work with Zebra to accelerate its development. Read more


3. TransMedics closes $51.2m round to support its Organ Care System

MassDevice.com news

TransMedics said today it closed a $51.2 million round of equity financing to support its Organ Care System organ preservation device.

The company’s flagship Organ Care System is designed to perfuse donor organs with warm, oxygenated blood and monitor its status until transplantation. Read more


2. Diabetes Tech Society releases cybersecurity standards for connected devices

MassDevice.com news

The Diabetes Technology Society this week released its cybersecurity standards for network-connected smart medical device as cyberattacks and data breaches become more commonplace.

The group released a public platform, called DTSec, which contains performance requirements the group says will improve cybersecurity through “independent expert security evaluation,” according to Healthcare IT NewsRead more


1. FDA panel backs St. Jude’s Amplatzer stroke device in 15-1 vote

MassDevice.com news

An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune.

The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke. Read more

The post MassDevice.com +5 | The top 5 medtech stories for May 26, 2016 appeared first on MassDevice.



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