BREAKING: Tom Price is out as HHS secretary

Tom Price has resigned from his post as U.S. health and human services secretary after days of fending off criticism over chartered flights he took on the public dime.

The announcement today out of the White House said Don J. Wright – presently assistant secretary for health and director of the Office of Disease Prevention and Health Promotion – will take over as acting secretary.

The announcement came minutes after President Donald Trump, at his Bedminster, N.J. gold course, told reporters that he didn’t like the “optics” around the hundreds of thousands of taxpayer dollars spent on Price’s flights – and that he was “not happy,” according to media reports in the Washington Post, Associated Press and elsewhere.

 

 

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7 medtech stories we missed this week: Sept. 29, 2017

[Image from unsplash.com]

From EOI getting FDA clearance to Sanuwave’s new joint venture agreement, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. EOI wins FDA nod for FLXfit15 expandable cage

EOI announced in a Sept. 28 press release that it has received FDA 510(k) clearance for its FLXfit 15. The clearance will help enhance the company’s FLXfir 3D expandable cage system and help expand the surgeon’s flexibility and capability by offering different length options.

2. ivWatch inks distribution deal with Terumo

ivWatch has recently signed a licensing and distribution agreement with Terumo to improve patient safety, according to a Sept. 21 press release. Terumo will become the exclusive distributor of the ivWatch Model 400 and ivWatch OEM board in Japan. ivWatch technology can be integrated with other patient monitoring systems, infusion pumps and other devices easily with the ivWatch OEM board. The agreement also allows Terumo to exclusively integrate ivWatch into existing and future Terumo products in Japan.

3. FDA clears Mortise Medical’s LigaMetrics suture anchor system

Mortise Medical announced in a Sept. 26 press release that it has received FDA 510(k) clearance for its LigaMetrics Suture Anchor System. The LigaMetrics Suture Anchor System is the first and only knotless suture anchor that allows for precise, measured tension control of the suture repair construct. The system is designed to connect to and lock suture tape that is attached to soft tissue or a conventional suture anchor.

4. Lombard Medical launches Aorfix delivery device in Japan

Lombard Medical has commercially launched its new delivery system for the Aorfix AAA system, according to a Sept. 26 press release. The new delivery system is marketed in Japan by Medico’s Hirata and is used to deliver Lombard’s Aorfix AAA stent graph.

5. FDA expands clearance for Cefaly migraine device

Cefaly announced in a Sept. 21 press release that the FDA has expanded its clearance for Cefaly Acute migraine treatment. The device is used for the acute treatment of migraines in patients 18 years or older. The Cefaly Acute allows migraine sufferers to use the device during a migraine attack which makes it more than a preventative measure.

6. Varian touts first use of Halcyon oncology system

Varian Medical System has announced that the first patient in the world has been treated using Varian’s Halcyon system, according to a Sept. 21 press release. The patient had head and neck cancer. The system is suited to offer advanced treatments for prostate, breast, head and neck and other forms of cancer.

7. Sanuwave inks JV deal with Brazil’s Mundimed

Sanuwave announced in a Sept. 28 press release that it has signed a joint venture agreement with Mundimed in Brazil. The agreement states that the companies will split profits in the wound care industry while using the dermaPACE technology. The net present value is expected to exceed $25M. Sanuwave will also receive an undisclosed amount of cash payments beginning Sept. 30 and the payments will continue through 2019.

Here’s what we missed last week.

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Promaxo closes $3.5m Series A for office-based, high-res MRI

Promaxo, Inc., said today that it closed a $3.5 million Series A round to fund its clinical validation and regulatory efforts for the company’s office-based, high-resolution MRI.

MicroPort Scientific led the round and in connection with its investment, MicroPort was given exclusive manufacturing and distribution rights for Promaxo’s MRI tech in China.

The company has designed a suite of prostate cancer disease management solutions to change the screening, diagnosis and treatment process for the disease.

“We are thrilled to have MicroPort on board as a strategic investor and partner,” president & CEO Amit Vohra said in prepared remarks.

“The partnership will allow us to leverage MicroPort’s brand, talents, and global footprint to scale Promaxo’s MRI platform, and bring an office-based MRI to the masses.”

The company also announced today that it added Diego Olego its advisory team, who has previously held roles like chief strategy and innovation officer at Philips Healthcare.

“I am excited to be joining the Promaxo team,” Olego added. “I believe that Promaxo’s mobile innovative MR platform promises broad clinical and workflow impact, especially for prostate cancer patients.”

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Humacyte lands $14m to expand uses for human acellular vessel

Humacyte said today that it landed a $14.1 million award from the California Institute for Regenerative Medicine to support a clinical trial comparing its human acellular vessel, Humacyl, to arteriovenous fistulas – the traditional way to create vascular access in patients who need hemodialysis.

The Research Triangle Park, N.C.-based company said it plans to evaluate Humacyl as a conduit for hemodialysis in a group of patients with end-stage renal disease who need renal replacement therapy.

“This significant and incremental investment from CIRM further validates the potential of our bioengineered human acellular vessel’s capabilities as a more durable and safe vascular access option for patients requiring dialysis treatment,” CMO Dr. Jeffrey Lawson said in prepared remarks.

“Based on the early promising signals from our Phase II study results published in The Lancet last year, and the positive data that we expect from our ongoing Phase III trials comparing the Humacyl to ePTFE grafts, we envision broader opportunities for Humacyl beyond an alternative to synthetic grafts, starting with this newest study comparing our product to arteriovenous fistulas.”

Humacyte said it expects results from its pivotal Humanity trial later next year. From there, it hopes to submit a biological license application to the FDA for its human acellular vessel.

Earlier this year, Humacyte won the regenerative medicine advanced therapy designation from the FDA, helping to speed up the development and review of Humacyl.

“CIRM recognizes the challenges faced by more than 465,000 patients in the U.S. undergoing hemodialysis procedures with few effective vascular access options available to them, and we deeply appreciate this significant support,” chairman & CEO Carrie Cox added.

“This additional funding enables Humacyte to explore the use of our innovative technology to treat a broader range of patients suffering from ESRD that need hemodialysis as a life-saving treatment. With Humacyl, we hope to realize our vision to provide better healthcare options for patients through a more durable, biological alternative, while lowering the costly and deadly risk of infection and higher rates of abandonment of current synthetic alternatives.”

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MassDevice.com +5 | The top 5 medtech stories for September 29, 2017

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. Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem

Bigfoot Biomedical‘s chief executive is excited about Abbott‘s latest regulatory win – and it’s not just because the two companies have an established partnership.

Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use of routine finger sticks. Read more

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4. Leerink fund raises $313m for HIT plays

A fund backed by investment bank Leerink Partners raised $313 million for investments in the health information technology sector.

Boston-based Leerink Transformation Partners said its first fund was significantly oversubscribed compared with the $250 million it initially sought to raise. Co-founder Todd Cozzens is a medical device industry veteran and former Sequoia Capital partner; Dr. Jared Kesselheim, a internist, spent 8 years at Bain Capital Ventures. Read more

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3. Insulet “bets big” on Massachusetts with new manufacturing facility in Acton

Insulet broke ground at its new manufacturing facility in Acton, Mass. yesterday, hosting a ceremony that featured the state’s governor, Charlie Baker, members of Baker’s administration and a young “Podder” named Lexi Bentinganan.

Diagnosed at age 7 with Type I diabetes, Lexi has been using Insulet’s tubeless insulin delivery device, the Omnipod, since 2013. Read more

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2. Abbott plans to close $5B Alere buyout next week

Abbott said that it plans to close its once star-crossed merger with Alere next week, after U.S. and Canadian anti-trust regulators yesterday approved the deal subject to concessions.

Abbott agreed to divest a blood gas testing system to Siemens, which also agreed to buy two Alere facilities in Ottawa. Quidel Corp. is slated to buy Abbott’s heart function testing system business and an Alere facility in San Diego. Read more

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1. FDA warns on endoleaks with stent grafts

The FDA yesterday warned physicians about the risk for a dangerous type of leak with endovascular stent grafts used to wall off aneurysms in the abdominal aorta.

The federal safety watchdog said the warning was prompted by an uptick in adverse event reports from physicians and medical device companies of Type III endoleaks in stent grafts used to treat AAA and aorto-iliac-aneurysms. Type III endoleaks result from defects or mis-alignment of the stent graft components, allowing pressure to build in the aneurysm sac and increasing the risk of rupture. Read more

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Novo Nordisk wins FDA nod for fast-acting mealtime insulin

Novo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection.

The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported.

Get the full story at our sister site, Drug Delivery Business News.

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EU launches full-scale probe into $54B Essilor-Luxotica merger

The European Commission plans to investigate whether the €46 billion merger of Luxottica (NYSE:LUX) and Essilor (EPA:EI) could drive competitors away from the market or hike prices, according to Reuters.

The companies hold high-ranking positions in the ophthalmic lens and eyewear industries. Earlier this month, Luxottica and Essilor decided not to offer concessions in a preliminary review by antitrust authorities.

The agency said it plans to decide whether to clear the deal or not by February next year, but the two companies said they hope to close the merger at the end of this year.

“Both companies … will closely cooperate with the European Commission to fully demonstrate the rationale of the proposed combination,” they said in a joint statement, Reuters reported.

One concern that antitrust authorities have is that the merged company might encourage opticians to buy eyewear and lenses in packages. The Commission wants to ensure that Luxottica’s rivals have access to the lens market and Essilor’s rivals have access to the frames market.

“The final outcome will hinge to a large extent on concessions the two companies make to offset any foreclosure risks,” Luciano Di Via, head of antitrust affairs for Italy, told the newswire.

“Usually in situations such as this, behavioural remedies are requested, the commission may demand commitments from the two companies in terms of commercial practices, a request to sell certain assets is more unlikely.”

“Half of Europeans wear glasses and almost all of us will need vision correction one day,” European Competition Commissioner Margrethe Vestager told Reuters.

“We need to carefully assess whether the proposed merger would lead to higher prices or reduced choices for opticians and ultimately consumers.”

The merger is still waiting for clearance in the U.S., but it has been approved in India, Japan and New Zealand.

($1 = 0.8490 euros)

Material from Reuters was used in this report.

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KKR puts another $35m into Signostics parent company EchoNous

Private equity giant KKR (NYSE:KKR) put another $235 million into EchoNous, the parent company of Signostics, for the second time in as many years.

The cash is earmarked for commercializing the Uscan ultrasound device, developing a vein-location device and an unnamed artificial intelligence-driven ultrasound project to market, Seattle-based EchoNous said. KKR put $35 million into the company back in November 2015.

“KKR has been a strong partner since our first investment round together, so we are very pleased to receive additional support from them as we build a world-class company dedicated to solving everyday problems in health care by fusing machine learning and miniaturized ultrasound,” EchoNous CEO Kevin Goodwin said in prepared remarks. “We are confident that with KKR’s continued investment, we will accelerate Uscan’s market share in hospitals across the country, bringing a series of highly innovative, intelligent and unique health care tools to those who need them.”

“EchoNous is approaching ultrasound with a unique, AI-driven focus that we believe will revolutionize the way this technology is used in patient care,” added chairman & KKR healthcare director Justin Sabet-Peyman. “The rapid adoption of Uscan demonstrates the company’s ability to execute on its innovative approach to ultrasound technologies, and we are excited about its ongoing development of new intelligent devices to improve health care.”

Back in 2015 Signostics said it planned to use the original $35 million to fuel its R&D program and pay for expanding its worldwide commercial footprint. The company’s Sonimage P3 won 510(k) clearance from the FDA in 2013; a new product is on tap for 2016, and Signostics said at the time that it was planning “a series of breakout advancements in ultrasound technology.”

Signostics drafted Goodwin in April 2015, following SonoSite’s $1 billion acquisition by Fujifilm Holdings (TSE:4901). The company said it shifted its corporate domicile and headquarters from Clovelly Park, Australia, to Kirkland, Wash., before consummating the deal with KKR.

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Appeals court upholds Boston Scientific win over stent pioneer Jang

A federal appeals court today upheld a Boston Scientific (NYSE:BSX) win over coronary stent pioneer Dr. David Jang.

The case dates back to 1999, when Jang won approval from the U.S. Patent & Trademark Office for a stent design featuring lateral struts. In 2002, Jang inked a deal worth up to $160 million to license the patents to Marlborough, Mass.-based Boston Scientific; Jang received $50 million up front, according to court documents, but only $10 million of the remaining $110 million in milestone payments.

Jang sued in 2005, alleging breach of contract and other claims. Boston Scientific filed a counterclaim in 2006 “denying any obligation to make additional contingent payments to Jang on the ground that that the accused stents did not infringe,” and thus were not covered under the deal with Jang, according to the documents.

Judge Virginia Phillips of the U.S. District Court for Central California initially ruled that the Boston Scientific stents did not infringe the Jang patents, shot down the breach of contract claim and decided the other claims in Boston’s favor. After Jang appealed, the Federal Circuit in 2012 vacated the ruling and remanded it to Phillips.

A Patent Office re-examination in 2013 found the Jang patents invalid, prompting Boston Scientific to argue that it shouldn’t be required to pay royalties on invalid patents. Phillips denied that bid for summary judgment, ruling that Jang has the right to demand royalties covering the time up until Boston Scientific asked for the re-examination, according to the documents. Boston appealed, asking the Federal Circuit to review the Phillips decision; the appeals court in September 2014 declined to hear the petition. At trial the jury sent up a split verdict, finding that Boston Scientific did not literally infringe the Jang patents but did infringe under the doctrine of equivalents. Phillips found in 2015 that Jang’s claims covered previous patents, triggering an ensnarement defense barring a patentee from asserting a scope of equivalency that would encompass, or ensnare, the prior art.

Jang moved for judgment as a matter of law on the jury’s finding of no literal infringement, but Phillips found enough evidence to support the verdict and rejected Jang’s bid for a new trial. Jang appealed that decision, arguing that a reasonable jury couldn’t have found no literal infringement because the undisputed facts showed otherwise and Boston Scientific’s non-infringement arguments were legally erroneous.

Today the U.S. Court of Appeals for the Federal Circuit upheld Phillips’ ruling, according to the documents.

The jury heard Dr. Jang’s theory of infringement and his supporting evidence but nevertheless found that the Express stent did not literally infringe. The district court did not fail to consider Dr. Jang’s theory of infringement and it correctly found substantial evidence to support the jury’s finding that the Express stent’s microelements do not literally meet the connecting-strut-column-related limitations,” the appeals court found. “Dr. Jang failed to persuade the district court that BSC’s non-infringement arguments were legally erroneous. We are similarly unpersuaded.”

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Vagus nerve stim partly awakens patient from 15-year vegetative state

A 35-year-old patient in France who has been in a vegetative state for last 15 years demonstrated signs of awareness after scientists electrically stimulated the patient’s vagus nerve, according to a study published in Cell this week.

After nerve stimulation, the patient was able to follow an object with his eyes and turn his head when asked, the scientists reported.

“These findings show that stimulation of the vagus nerve promoted the spread of cortical signals and caused an increase of metabolic activity leading to behavioral improvement as measured with the CRS-R scale and as reported by clinicians and family members,” the researchers wrote.

“Thus, potentiating vagus nerve inputs to the brain helps to restore consciousness even after many years of being in a vegetative state, thus challenging the belief that disorders of consciousness persisting after 12 months are irreversible.”

The team noted that EEG scans demonstrated an increase in theta band power after stimulation, particularly in the parietal, temporal and occipital regions of the brain. This part of the brain is known as a “hot-zone for conscious awareness,” according to the researchers.

Although the approach was successful for this France-based patient and has worked with a few others around the globe, nerve stimulation as a means to awaken vegetative patients has yet to be studied in a major trial.

There’s “strongly accumulating evidence that it is possible in many cases to increase brain activity after severe injury,” Dr. Nicholas Schiff, a neurologist at Weill Cornell Medicine and New York Presbyterian, told Stat. 

But he added that “there is essentially no infrastructure to have clinical follow-up” or “larger investigative studies.”

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Study: Transcranial e-stim beneficial in mild traumatic brain injury

Researchers from the University of California San Diego and from the Veterans Affairs San Diego Healthcare System have improved neural function in a group of people with mild traumatic brain injury using low-impulse electrical stimulation to the brain, according to a study published in Brain Injury.

Although little is understood about the pathology of mild TBI, the team of researchers noted that previous work has shown that passive neuro-feedback, low-intensity pulses applied to the brain through transcranial electrical stimulation, has promise as a potential treatment.

The team’s pilot study enrolled six people with mild TBI who were experiencing post-concussion symptoms. Researchers used a form of LIP-tES combined with concurrent electroencephalography monitoring and assessed the treatment’s effect using a non-invasive functional imaging technique, magnetoencephalography, before and after treatment.

“Our previous publications have shown that MEG detection of abnormal brain slow-waves is one of the most sensitive biomarkers for mild traumatic brain injury (concussions), with about 85 percent sensitivity in detecting concussions and, essentially, no false-positives in normal patients,” senior author Dr. Roland Lee said in prepared remarks. “This makes it an ideal technique to monitor the effects of concussion treatments such as LIP-tES.”

Researchers reported that the brains in all six patients had abnormal slow-waves at the time of initial scans. After treatment, MEG scans showed reduced abnormal slow-waves and the study participants reported a significant reduction in post-concussion scores.

“For the first time, we’ve been able to document with neuroimaging the effects of LIP-tES treatment on brain functioning in mild TBI,” first author Ming-Xiong Huang added. “It’s a small study, which certainly must be expanded, but it suggests new potential for effectively speeding the healing process in mild traumatic brain injuries.”

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Abbott plans to close $5B Alere buyout next week

Abbott (NYSE:ABT) said today that it plans to close its once star-crossed merger with Alere (NYSE:ALR) next week, after U.S. and Canadian anti-trust regulators yesterday approved the deal subject to concessions.

Abbott agreed to divest a blood gas testing system to Siemens (NYSE:SI), which also agreed to buy two Alere facilities in Ottawa. Quidel (NSDQ:QDEL) Corp. is slated to buy Abbott’s heart function testing system business and an Alere facility in San Diego.

Abbott offered to acquire Alere in February 2016. After several snafus, the company finally agreed to purchase Alere for $5.3 billion – down from its initial $5.8 billion price tag. The deal is now slated to close Oct. 3, Abbott said. Alere yesterday agreed to pay more than $13 million to settle SEC charges that it committed accounting fraud.

“Creating the world’s leading point of care business will help Abbott meet the growing demand for fast, accurate and actionable information,” diagnostic products EVP Brian Blaser said in prepared remarks. “Combined with Abbott’s existing point-of-care business and its leading hand-held platform, i-Stat, we now have the broadest point of care testing portfolio to help improve care for patients in more parts of the world.”

Abbott said the Alere buyout should take its diagnostics revenues to about $7 billion annually.

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Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem

Bigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership.

Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use of routine finger sticks.

“It’s a tremendous demonstration that the FDA understands the value of factory calibration and making usage of a sensor simpler and easier,” Bigfoot CEO Jeffrey Brewer told Drug Delivery Business News.

Get the full story at our sister site, Drug Delivery Business News.

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Biolase seeks up to $12m with rights offering

Biolase (NSDQ:BIOL) said today that it’s hoping to raise up to $12 million with a rights offering that’s already guaranteed to bring in $6 million.

The Irvine, Calif.-based dental laser maker said it hopes the offering will bring in at least $8 million, noting that affiliates of Larry Feinberg and Jack Schuler have each pledged to at least $3 million apiece. The exact pricing and number of shares involved have not been determined.

Last month Biolase posted a 134% increase in second-quarter net losses, which reach -$8.3 million, or -12¢ per share, on a -8.7% sales decline to $12.6 million compared with Q2 2016.

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Leerink fund raises $313m for HIT plays

A fund backed by investment bank Leerink Partners raised $313 million for investments in the health information technology sector.

Boston-based Leerink Transformation Partners said its first fund was significantly oversubscribed compared with the $250 million it initially sought to raise. Co-founder Todd Cozzens is a medical device industry veteran and former Sequoia Capital partner; Dr. Jared Kesselheim, a internist, spent 8 years at Bain Capital Ventures.

“We are distinctly positioned to help the best healthcare IT and services companies and their leaders accelerate their growth because of our differentiated backgrounds as founders, operators, clinicians, and investors,” Cozzens said in prepared remarks.

“We built a fund entirely focused on healthcare IT and services because of two key transformative tailwinds: The rapid adoption of information technology and the $3 trillion reimbursement shift underway from fee-for-service medicine toward value-based care,” Kesselheim added. “These drivers have created an unprecedented opportunity for disruption in a massive market whose complexity is best addressed by a fund with 100% sector focus.”

The inaugural fund also manages a $28 million pool, the Massachusetts Innovation Catalyst Fund, a $28 million fund, for backing Massachusetts-based companies.

“Massachusetts is home to some of the top hospitals and biopharmaceutical companies in the world and has abundant software engineering talent, so it is a natural geography to excel in developing healthcare IT businesses,” Kesselheim said. “We’re thrilled to build great local relationships and contribute to the Massachusetts healthcare ecosystem with the MICF.”

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FDA warns on endoleaks with stent grafts

Image: Ulster Medical Journal

The FDA yesterday warned physicians about the risk for a dangerous type of leak with endovascular stent grafts used to wall off aneurysms in the abdominal aorta.

The federal safety watchdog said the warning was prompted by an uptick in adverse event reports from physicians and medical device companies of Type III endoleaks in stent grafts used to treat AAA and aorto-iliac-aneurysms. Type III endoleaks result from defects or mis-alignment of the stent graft components, allowing pressure to build in the aneurysm sac and increasing the risk of rupture.

“This increase is compared to earlier clinical update reports in patients with various device models and implant duration lengths, including some patients who had previously stable repairs,” the FDA said.

The agency recommended that doctors maintain lifelong surveillance of patients treated with stent grafts.

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Industry trade groups want full MDR, IVDR implementation in U.K. post-Brexit

By Stewart Eisenhart, Emergo Group

Medical device and IVD trade groups in Europe and the UK have appealed to maintain a uniform system for CE Marking and regulatory oversight as negotiators work out British withdrawal from the European Union under Brexit.

Get the full story here at the Emergo Group’s blog.

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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Insulet “bets big” on Massachusetts with new manufacturing facility in Acton

Insulet (NSDQ:PODD) broke ground at its new manufacturing facility in Acton, Mass. yesterday, hosting a ceremony that featured the state’s governor, Charlie Baker, members of Baker’s administration and a young “Podder” named Lexi Bentinganan.

Diagnosed at age 7 with Type I diabetes, Lexi has been using Insulet’s tubeless insulin delivery device, the Omnipod, since 2013.

“It has given me complete control over my diabetes and reminded me that I’m just a normal kid,” she told the crowd of people gathered at Insulet’s 26-acre site.

Get the full story at our sister site, Drug Delivery Business News.

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Cogentix backs Vensica Medical and its needle-free drug delivery system

Cogentix Medical (NASDAQ: CGNT) said today that it invested $2 million in privately-held Vensica Medical and its ultrasound-based, needle-free drug delivery device, VensiCare.

Israel-based Vensica Medical is developing its VensiCare device as a way to deliver botulinum toxin to treat overactive bladder. The company also has IP for the delivery of oncology agents to the bladder, according to Cogentix.

Get the full story at our sister site, Drug Delivery Business News.

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Avita Medical submits PMA app for ReCell burn injury treatment

Avita Medical (ASX:AVH) said today that it submitted its pre-market approval application to the FDA for its ReCell autologous cell harvesting device.

The company’s system is designed to reduce the amount of skin harvesting needed to treat burn injuries compared to conventional treatments.

Get the full story at our sister site, Drug Delivery Business News.

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Masimo launches RAS-45 respiration sensor for Rainbow system

Masimo (NSDQ:MASI) said today it initiated a full market release of its RAS-45 adhesive adult and pediatric acoustic respiration sensor for its Rainbow acoustic monitoring system.

The Irvine, Calif.-based company’s Rainbow acoustic monitoring system is designed to non-invasively and continuously measure respiration rate with the adhesive sensor, which features an integrated acoustic transducer.

Masimo said that the RAS-45 features a smaller size, making it more useful for pediatric patients or patients with shorter necks, the company said. The device features transparent adhesive and greater flexibility than its RAS-125c adhesive.

“RAM harnesses the power of our breakthrough signal processing technology and applies it to a respiratory measurement derived from the sound of breathing. With the addition of the RAS-45 sensor, RRa is now a more convenient and comfortable measurement for clinicians and patients—especially children,” founder & CEO Joe Kiani said in a press release.

Earlier this month, Masimo said it won FDA 510(k) clearance for its Rad-97 pulse co-oximeter and launched the device in the US.

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Avinger wins CE Mark for in-stent restenosis indication for image-guided atherectomy

Avinger (NSDQ:AVGR) said today that it won CE Mark approval for treating in-stent resenosis with its Pantheris Lumivascular atherectomy system.

The company’s Lumivascular tech enables physicians to see from inside the artery during a directional atherectomy procedure in real-time, Avinger touted, using optical coherence tomography. The device is designed to help physicians more accurately navigate their devices to treat peripheral artery disease.

“The demand for improved treatment options for in-stent restenosis is growing as physicians experience the accurate visualization and precision provided by state-of-the-art technologies such as the Pantheris Lumivascular atherectomy system,” president & CEO Jeff Soinski said in prepared remarks.

“CE Marking for this particular indication is an important milestone for Avinger that addresses an area of unmet clinical need for patients suffering from PAD. Onboard image guidance coupled with directional plaque excision offers the interventionist clear benefits when treating in-stent restenosis and represents another opportunity to improve patient outcomes.”

“Two elements thoughtful interventionists want to avoid during intervention are adventitia and stent struts,” founder & executive chairman Dr. John Simpson added. “Intravascular visualization combined with a directional mechanism in real time provides operators the information and precision needed to treat only diseased tissue without coming into contact with the stent struts or adventitia.”

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Hologic wins expanded FDA nod for Cynosure SculpSure

Hologic (NSDQ:HOLX) said today it won expanded FDA 510(k) clearance for its subsidiary Cynosure’s SculpSure non-invasive body contouring laser, now cleared to treat the submental area.

The new treatment indication expands the total for the company to 6, as the device is already cleared to treat the abdomen, flanks, back, inner and outer thighs, the Marlborough, Mass.-based company said.

“Most patients in the 57-person clinical trial received two brief treatments six weeks apart. The short treatment time, 100% satisfaction rate, and dramatic contour reductions typically seen in the study patients give SculpSure the edge as the treatment of choice for the submental area,” SculpSure clinical trial principal investigator Dr. Lawrence Bass said in a press release.

The SculpSure device is a body contouring laser device designed to disrupt and destroy fat cells under the skin through treatments lasting approximately 25 minutes, the company said.

“We are encouraged that our chin treatment was proven effective on patients with a body mass index up to 43, while our competition in the non-invasive arena is only FDA-cleared to treat patients with a BMI up to 30. We are excited to provide our customers with a competitive advantage that can further widen their patient communities,”  Cynosure division prez Kevin Thornal said in a prepared statement.

In late August, Hologic said it launched its Brevera breast biopsy system designed for real-time breast biopsy and verification.

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U.S. antitrust agency approves Abbott’s Alere purchase – with conditions

The Federal Trade Commission said today that it approved Abbott‘s (NYSE:ABT) bid to buy Alere (NYSE:ALR) as long as the company sells two of its point-of-care medical testing businesses.

Canada echoed the announcement, saying it approved the proposed deal on similar terms.

The FTC reported that Abbott agreed to divest a blood gas testing system to Siemens Aktiengesellschaft, which also agreed to buy two Alere facilities in Ottawa. Quidel Corp. is slated to buy Abbott’s heart function testing system biz and an Alere facility in San Diego.

Alere’s shares were up 3.5% today, trading at $50.61 apiece in mid-afternoon activity, while Abbott was up 3% at $53.72 per share.

Abbott offered to acquire Alere in February last year and after several snafus, the company finally agreed to purchase Alere for $5.3 billion – down from its initial $5.8 billion pricetag.

Also today, Alere agreed to pay more than $13 million to settle SEC charges that it committed accounting fraud.

Material from Reuters was used in this report. 

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Medtrobotics submits FDA application for transabdominal robotic scope

Medrobotics said today it submitted an application to the FDA as it seeks clearance for a flexible transabdominal robotic scope designed to visualize anatomy in the thoracic and abdominal cavities.

The Raynham, Mass.-based company produces the Flex robot-assisted surgery platform, which is designed for transoral, colorectal and other minimally invasive procedures. The company touts the system as the 1st to offer minimally invasive and steerable robotic products for colorectal applications.

Medrobotics said that the submission reaffirms its “commitment to develop products for single-port general, gynecological and urological surgeries, according to a press release.

In May, Medrobotics won indications for colorectal procedures with the Flex system from the FDA, and won similar expanded CE Mark approval in the European Union last October.

The system won 510(k) clearance from the FDA for transoral procedures in July 2015 (that indication won CE Mark approval back in March 2014).

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MassDevice.com +5 | The top 5 medtech stories for September 28, 2017

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. Four top medtech stories you need to know in late 2017

The U.S. government continues to create a lot of uncertainty for the medical device industry, but medtech companies are still making some big moves.

The frenzy of major mergers continues, which makes sense from an investor standpoint when it comes to reducing risk. Meanwhile, companies from outside the industry – including such high-tech giants as Apple, Google and Microsoft – see medical as a great way to diversify and hedge bets. Read more

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4. Dexcom CEO: Bringing meaningful data to the diabetes community

Kevin Sayer describes Dexcom‘s history as punctuated by “firsts” – its continuous glucose meter was the first to connect to a phone. Last year, the company’s tool became the first to be approved by the FDA as one from which a patient with diabetes can make insulin dosing decisions.

When Sayer took the helm as president & CEO of Dexcom in 2011, he was no stranger to the diabetes space. He served as the CFO of MiniMed from 1994 until it was bought by Medtronic in 2001, at which point he joined the medtech giant’s diabetes business. Read more

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3. India’s NPPA tells Boston Scientific to choose between exiting stent market or seeking higher price caps

India’s National Pharmaceutical Pricing Authority has told Boston Scientific it has to choose between either seeking to withdraw its premium coronary stents from the market or seeking a higher price for them after the Authority received applications for both options, according to an Indian Economic Times report.

The company was blocked from removing its Promus Premier and Synergy stents from the country earlier this year after seeking permission to do so, according to the report, and has again approached the NPPA seeking permission to exit the market. Read more

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2. BD offers EU concessions in $24B Bard acquisition

Becton Dickinson has offered concessions to address certain EU antitrust concerns as it looks to acquire C.R. Bard in a $24 billion deal, according to the European Commission.

Franklin Lakes, N.J.-based Becton Dickinson submitted the concessions yesterday, according to a filing on the EU competition authority, but did not provide any details on the submission. Read more

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1. Medtronic wins expanded FDA nod for HeartWare HVAD as destination therapy

Medtronic said today it won expanded FDA approval for its HeartWare HVAD system, now cleared as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants.

The HeartWare HVAD system is a left ventricular assist device designed to aid the heart and increase the amount of blood pumped through the body, the Fridley, Minn.-based company said. Read more

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Tandem touts adoption of CGM update to t:slim X2 insulin pump

Last month, Tandem Diabetes Care (NSDQ:TNDM) announced that the FDA approved its t:slim X2 insulin pump integrated with Dexcom‘s (NSDQ:DXCM) G5 mobile continuous glucose monitor.

The San Diego, Calif.-based company made the software available to its current t:slim X2 pump users at no additional cost, enabling them to add CGM-integration to their existing devices.

Get the full story at our sister site, Drug Delivery Business News.

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Angiodynamics shares tumble on Q1 sales, EPS miss

Shares in AngioDynamics (NSDQ:ANGO) have dropped over 10% today after the medical device maker missed expectations on Wall Street with its 1st quarter results.

The Albany. N.Y.-based company posted losses of $35,000, or 0¢ per share, on sales of $85.4 million for the 3 months ended August 31, seeing the bottom-line swing 102.7% into the red while sales shrunk 3.1% compared to the same period the previous year.

After adjusting to exclude 1-time items, earnings per share were 12¢, behind the 16¢ consensus on Wall Street, where analysts were expecting to see sales of $86.1 million for the quarter.

“The 1st quarter of fiscal 2018 reflects early results of our commitment to improving our core operational efficiency and strengthening our business. Sales for our oncology/surgery business saw an 11% increase over last year, primarily driven by Solero, which received FDA clearance during the fiscal 2017 4th quarter. In addition, we saw strong sales from other areas of our business, including Fluid Management, Thrombus Management, the BioFlo family of products and NanoKnife disposables. We remain committed to our strategic plan and will continue to invest in the right areas to drive sustainable, long-term growth,” prez & CEO Jim Clemmer said in a press release.

“There were a couple of factors that impacted our financial results during the 1st quarter when compared to prior year, including decisions we made to address the recall and voluntary market withdrawal of Acculis and the inventory build in our core/angiographic catheter business. Our results for the 1st quarter were in-line with our expectations and given the strength of our overall execution we are reaffirming our fiscal 2018 guidance to reflect that confidence,” CFO Michael Greiner said in a prepared statement.

Angiodynamics reaffirmed its fiscal year 2018 financial guidance, expecting to see sales between $352 and $359 million and adjusted earnings per share of between 64¢ and 68¢.

Shares in Angiodynamics have dropped 13.2% so far today, at $16.29 as of 1:31 p.m. EDT.

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4 top medtech stories you need to know in late 2017

[Image from istockphoto]

The U.S. government continues to create a lot of uncertainty for the medical device industry, but medtech companies are still making some big moves.

The frenzy of major mergers continues, which makes sense from an investor standpoint when it comes to reducing risk. Meanwhile, companies from outside the industry – including such high-tech giants as Apple, Google and Microsoft – see medical as a great way to diversify and hedge bets.

Here are the top medtech stories that caught our eye in recent months. (We’ll also discuss these stories more during an Oct. 11 webinar.)

Next>>

(Learn from some of the medical device industry’s top executives and experts at DeviceTalks Boston on Oct. 2.)

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Alere to pay $13m to settle SEC accounting fraud charges

Alere (NYSE:ALR) has agreed to pay more than $13 million to settle charges claiming it committed accounting fraud through its subsidiaries, according to an SEC release posted today.

The Commission said that Alere was charged with committing accounting fraud through its subsidiaries to meet revenue targets and making improper payments to foreign officials to increase sales in select countries.

The charges are against the South Korean subsidiary of Alere which sells diagnostic testing equipment, according to the SEC. The SEC said it issued an order which found that the subsidiary “improperly inflated revenues by prematurely recording sales for products that were still being stored at warehouses or otherwise not yet delivered to their customers.”

“Our securities laws give investors the right to a fair picture of public companies’ finances. For Alere, that picture was distorted by multiple accounting failures and by outright fraud,” SEC Boston Regional Office director Paul Levenson said in a prepared statement.

The SEC said its order also found that subsidiaries in India “obtained or retained business” by making improper payments, through distributors or consultants, to officials of government agencies or governmentally controlled entities. It also stated that  Alere “failed to maintain adequate internal controls to prevent the payments,” and had inaccurately recorded the payments in its records.

Without admitting to or denying the findings, Alere agreed to pay $3.3 million in disgorgement for ill-gotten gains, as well as interest of $495,196 and a penalty of $9.2 million, according to the SEC.

In August, a Massachusetts federal judge dismissed most of a securities fraud class action case against Alere, saying that the complaint did not support the claim that Alere senior management had prior knowledge of the company’s alleged wrongdoing.

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Titan Medical adds Columbia University Med Center to Sport feasibility trials

Titan Medical (TSX:TMD) said today it inked a deal to add Columbia University Medical Center to the feasibility and validation studies of its robotic Sport surgical system.

The Toronto-based company said it expects the study to commence at Columbia by the 4th quarter of 2017 and into 2018.

“Single port robotic surgery has tremendous potential to be the next frontier in GYN and other surgical specialties. We are excited to be partnering with Titan Medical in shaping the future of single port robotic surgery during critical development phases of their Sport system. We have the expertise and facilities to provide valuable input during the development process,” Dr. Arnold Advincula, of Columbia University Medical Center said in a prepared statement.

The company has already inked a deal with the French Institut Hospitalo-Universitaire de Strasbourg and with the Florida Hospital Nicholson Center to join the feasibility and validation study.

“We are honored to partner with another leading academic medical center in Columbia University Medical Center, a New York Presbyterian Hospital for continued feasibility and validation studies for the Sport system. Considered as one of the leading U.S. hospitals, Columbia University Medical Center provides global leadership in scientific research, health and medical education and patient care. Through this collaboration, Titan’s Sport system will be installed at the Roy and Diane Vagelos Education Center, a brand new state-of-the-art medical and graduate education center with full access to laboratory facilities as well as Columbia’s multi-specialty and world-renowned surgeons. With the signing of this agreement, I am glad to announce that Titan has delivered on its critical milestone of establishing formal collaborations with 3 strategic centers of excellence. Following the agreements with Florida Hospital Nicholson Center, IHU Strasbourg and now, Columbia University Medical Center, we eagerly look forward to continuing the feasibility studies in the 4th quarter of 2017,” prez & CEO David McNally said in a press release.

The company said earlier this month that it installed the 1st Sport system at the Florida Hospital Nicholson Center as it looks to begin testing.

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SteadyMed requests meeting with FDA over rejected application for drug-device combo

Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent.

SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the FDA in June, but the federal watchdog has requested more information on certain device specifications and performance testing, as well as additional design verification and validation testing.

Get the full story at our sister site, Drug Delivery Business News.

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FDA deals setback to Intarcia for diabetes implant

Privately-held biopharma Intarcia Therapeutics revealed today that the FDA rejected its exenatide implant, ITCA 650, designed to treat Type II diabetes.

The company said that it doesn’t think it will need to conduct new pivotal trials in order to address the concerns brought about by the FDA’s complete response letter.

Get the full story at our sister site, Drug Delivery Business News.

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Abiomed joins $15m round for acute heart failure treatment dev Magenta Medical

Novel acute heart failure treatment developer Magenta Medical said it closed a $15 million Series B round of financing, joined by transcatheter heart pump dev Abiomed (NSDQ:ABMD).

Investors in the Israel-based company included Pitango Venture capital, JAFCO and a group of industry investors led by Dr. Jacques Seguin, who founded CoreValve. Dr. Seguin will also join the company’s board of directors as part of the funding round.

Magenta Medical was founded in 2012 and is developing “novel therapeutic approaches to the management and treatment of acute heart failure.” The treatment is based around a catheter-based therapy which aims to manage congestion through faster and safer fluid and salt removal while protecting kidney function, the company said.

“Since its inception, Magenta has made great progress and was able to bring its first product into clinical trials in Europe. The current funding will allow us to expand and accelerate the clinical program on the path to approval in Europe and a pivotal study in the U.S. With the company’s growth and my increased focus on the medical and clinical aspects of the operation, we as founders decided to extend an offer to our chairman, Dr. David Israeli, to serve as CEO of the company. We are delighted that David accepted and we look forward to a continued fruitful partnership,” Magenta co-founder & chief medical officer Dr. Schwammenthal said in a prepared statement.

The founders of Magenta Medical, Dr. Ehud Schwammenthal and Yosi Tuval, also founded Ventor Technologies. Ventor developed a catheter-based system for the minimally invasive replacement of aortic valves, and was picked up by Medtronic in 2009 for $325 million.

“Having witnessed the progress of Magenta’s exciting technology as its Chairman of the Board, I was delighted to accept the role of CEO at Magenta Medical. Together with Prof. Schwammenthal and Mr. Tuval, both with a proven track record as medical device entrepreneurs, we aim to position Magenta as a groundbreaking company in the treatment of acute heart failure,” Magenta CEO Dr. David Israeli said in a prepared release.

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India’s NPPA tells Boston Scientific to choose between exiting stent market or seeking higher price caps

India’s National Pharmaceutical Pricing Authority has told Boston Scientific (NYSE:BSX) it has to choose between either seeking to withdraw its premium coronary stents from the market or seeking a higher price for them after the Authority received applications for both options, according to an Indian Economic Times report.

The company was blocked from removing its Promus Premier and Synergy stents from the country earlier this year after seeking permission to do so, according to the report, and has again approached the NPPA seeking permission to exit the market.

“The Authority deliberated and decided that NPPA, in any case, shall revisit the pricing of cardiac stents before February 13, 2018. It further noted that the company has submitted 2 applications, 1 for withdrawal and the other for price revision, both cannot be considered simultaneously. The company may be directed to forward one request by withdrawing the other request and till then both the request may be kept in abeyance,” minutes from the NPPA’s latest authority meeting read, according to The Economic Times.

Marlborough, Mass.-based Boston Scientific has not yet officially commented on the process or its intentions as of its last submission to the NPPA.

Earlier this month, the NPPA said it won’t be revising its cap on coronary stents, applied earlier this year, until Feb. 2018, according to a LiveMint report.

The regulatory body for India established price caps earlier this year that cut prices on coronary stents by over 80%, causing major players in the region to seek an exit from the market.

Stent makers, including major players Abbott (NYSE:ABT), Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ) and Boston Scientific have urged the NPPA to reconsider its price caps, and threatened to leave the market if the caps were not removed.

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BD offers EU concessions in $24B Bard acquisition

Becton Dickinson (NYSE:BDX) has offered concessions to address certain EU antitrust concerns as it looks to acquire C.R. Bard (NYSE:BCR) in a $24 billion deal, according to the European Commission.

Franklin Lakes, N.J.-based Becton Dickinson submitted the concessions yesterday, according to a filing on the EU competition authority, but did not provide any details on the submission.

The Commission has extended its deadline for a decision on the matter from Oct. 4 to Oct. 18 and may demand more concessions or a full-scale investigation, which could take approximately 4 months, if the companies fail to address its concerns.

In early August, Bard shareholders overwhelmingly approved the $24 billion merger with BD. The $317-per-share deal, which was announced last April, is expected to close during the fourth quarter, the companies said.

Consummation of the deal is still waiting on anti-trust approvals, including by the U.S. Federal Trade Commission. In June, the FTC asked for more information on the merger, adding 30 days to the timeline for closing the deal.

Material from Reuters was used in this report

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Medtronic wins expanded FDA nod for HeartWare HVAD as destination therapy

Medtronic (NYSE:MDT) said today it won expanded FDA approval for its HeartWare HVAD system, now cleared as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants.

The HeartWare HVAD system is a left ventricular assist device designed to aid the heart and increase the amount of blood pumped through the body, the Fridley, Minn.-based company said.

“LVADs are an effective and well-established treatment for patients who have progressed to advanced heart failure. In addition to its use as a bridge to heart transplantation, the HVAD System offers a promising option for a growing number of patients who are ineligible for transplant,” study co-principal investigator Dr. Joseph Rogers of Duke University said in a prepared release.

The new clearance comes based on results from the company’s Endurance and Endurance Supplemental trials, which evaluated nearly 1,000 destination therapy patients.

“Heart failure continues to be a growing burden to millions of patients, caregivers and the healthcare system. Medtronic strives every day to advance the field of mechanical circulatory support so we can offer physicians more solutions for patients who are living with this debilitating disease,” Medtronic heart failure biz GM Dr. David Steinhaus said in a press release.

Medtronic said that results from the trials supported that the system was safe and effective for patients with advanced, refractory left ventricular heart failure as a bridge to cardiac transplantation, or myocardial recovery, or as destination therapy for patients with no planned subsequent transplantation.

“We have been impressed with the overall clinical profile of the HVAD System, as evidenced by the Endurance and Endurance Supplemental trials, which affirmed its safety and effectiveness as a life-saving therapy for patients. The new indication is extremely important for patients with end-stage heart failure as the HVAD System offers significant survival and quality-of-life benefits,” study co-principal investigator Dr. Francis Pagani of the University of Michigan Health System’s Center for Circulatory Support said in a prepared statement.

In April, Medtronic said that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report  lowered stroke rates compared to standard treatment.

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Dexcom CEO: Bringing meaningful data to the diabetes community

Kevin Sayer describes Dexcom‘s (NSDQ:DXCM) history as punctuated by “firsts” – its continuous glucose meter was the first to connect to a phone. Last year, the company’s tool became the first to be approved by the FDA as one from which a patient with diabetes can make insulin dosing decisions.

When Sayer took the helm as president & CEO of Dexcom in 2011, he was no stranger to the diabetes space. He served as the CFO of MiniMed from 1994 until it was bought by Medtronic (NYSE:MDT) in 2001, at which point he joined the medtech giant’s diabetes business.

“I’ve always felt that continuous glucose monitoring is what really unlocks the door to the best possible outcomes you can have in treating diabetes across the board and those convictions have only increased as we’ve developed our technology here at Dexcom,” Sayer told Drug Delivery Business News. “The technology is so much better than what it was before and has the potential to be even much stronger than what it is now.”

Get the full story at our sister site, Drug Delivery Business News.

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FDA approves first glucose sensing tech that doesn’t require routine finger sticks

Abbott (NYSE:ABT) said yesterday that the FDA approved its FreeStyle Libre Flash glucose monitoring system as a replacement for blood glucose monitoring for adults with diabetes.

The company’s technology doesn’t require finger stick calibration and eliminates the need for users to routinely stick their fingers for samples.

Get the full story at our sister site, Drug Delivery Business News.

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MassDevice.com +5 | The top 5 medtech stories for September 27, 2017

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. Should the medical device industry pay user fees to CMS?

Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA?

That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by AdvaMed. Yared made the suggestion during a talk with Tamara Syrek Jensen, director of the coverage and analysis group at CMS, and Dr. Jeff Shuren, director of CDRH. Read more

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4. Analytics 4 Life lands $25m for AI-backed cardiac imaging tech

Analytics 4 Life said today that it landed $25 million in a Series B financing round. A group of investors, including doctors and medical device experts, contributed to the round.

The digital health company’s cardiac imaging tech is designed to help physicians assess the presence of coronary artery disease using signals from the body – without the use of radiation or contrast agents. Read more

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3. Boston Scientific launches third Connected Patient Challenge

Boston Scientific today announced the launch of its third annual Connected Patient Challenge, which it is holding in collaboration with Google and Medstro.

The last competition was about big data, artificial intelligence and patient-engagement technologies. This time around, the competition is offering winners up to $50,000 in services to help them realize their big idea about how to use the Internet of Things to improve diagnosis, treatment, monitoring or patient care. Read more

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2. 6 innovative pediatric devices you need to know

The creators of six innovative pediatric devices received a total $250,000 in prize money at the fifth annual Pediatric Device Innovation Symposium, co-located this year at AdvaMed’s The MedTech Conference in San Jose, Calif.

The event – organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System and sponsored by National Capital Consortium for Pediatric Device Innovation (NCC-PDI) – allows companies to showcase innovative medical device solutions that help meet needs in pediatric health. Read more

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1. FDA head Gottlieb says hurricane damage in Puerto Rico “bad, if not worse” than predicted

The impact of Hurricane Maria on the island of Puerto Rico, including its substantial medical device manufacturing hub, is “just as bad, if not worse, than predicted,” FDA Commissioner Dr. Scott Gottlieb said in a statement released yesterday.

Many companies are rushing to assess damages to their facilities after the storm, with industry groups like AdvaMed and the FDA undertaking efforts to help begin the process of recovery for not only the production facilities on the island, but the people and infrastructure as well. Read more

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