Siemens US CEO Spiegel to step down, Marks & Davis step up | Personnel Moves November 30, 2016

Siemens (NYSE:SI) said today that its U.S. CEO Eric Spiegel is retiring at the end of the year, with Lisa Davis slated to take the role of chair & CEO of the US-based Siemens Corporation, while Judith Marks will act as Siemens CEO U.S.

Both changes are slated to go into effect January 1, 2017, according to the company, and Marks will assume the CEO U.S. role in addition to her current position as exec VP at Siemens biz Dresser-Rand.

“In announcing my retirement, I am tremendously proud of what my team and I were able to accomplish over the last seven years for one of the world’s leading industrial companies in Siemens’ largest market. As the new Administration and Congress begin to outline their priorities, the time is right for Lisa and Judy to guide the company’s outreach and engagement from day one,” Spiegel said in a press release.

“Eric has grown Siemens’ business and furthered our reputation in the U.S. as a critical contributor to the country’s economic, manufacturing and innovation engines, and we thank him for his leadership. Judy has a deep knowledge of Siemens’ entire portfolio that will serve us well during this time of transition and into the future,” Davis said in a prepared statement.

Marks joined Siemens in 2011 as prez & CEO of Siemens Government Tech. She spent 27 years with Lockheed Martin prior to joining Siemens.

“I look forward to working with Lisa, Siemens employees, and Siemens’ customers during an exciting moment in the company’s history. Our mission is to make real what matters. It’s to continue setting the benchmark for electrification and automation for our customers while pushing into our newest chapter where we do the same with digitalization. This is a company that is uniquely capable of delivering immense value both to customers and to communities across the U.S.,” Marks said in prepared remarks.

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Smith & Nephew (NYSE:SNN) said it has picked up ex-Alvogen CFO Graham Baker to operate as the company’s new chief financial officer as well as joining the board as an exec director. The move is slated to go into effect March 1, 2017.

“Graham’s blue-chip experience, deep sector knowledge and extensive exposure to established and emerging markets set him apart as the ideal next CFO for Smith & Nephew. He has a strong track record of delivering operational excellence and has relevant experience across major finance roles and geographic markets, leading large teams responsible for significant budgets. With his hands-on approach, I have no doubt that he will successfully ensure effective financial stewardship for Smith & Nephew,” CEO Olivier Bohuon said in prepared remarks.

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Echo Therapeutics (NSDQ:ECTE) said last week it tapped current CFO Alan Schoenbart as its new interim CEO, replacing former CEO Scott Hollander, who departed from the company in late September.

Schoenbart is slated to keep his current position as chief financial officer in addition to the CEO spot.

 

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CryoLife Inc. (NYSE:CRY) said in September it hired James ex-Medtronic (NYSE:MDT) cardiac & vascular HR group VP James McDermid as its new chief human resources officer.

“Jim has a proven track record as a human resources leader and we are fortunate to have him join the CryoLife team. Given his experience leading the HR team for one of the largest cardiovascular businesses in the world, he is well positioned to enhance CryoLife’s HR programs as we continue to grow our business. I worked personally with Jim in my time at Medtronic and am confident that he will add a valuable perspective and be a driving force in further improving the experience and development opportunities for our employees around the world,” CEO Pat Mackin said in a prepared statement.

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Motus GI said yesterday it tapped James Martin as its chief financial officer, moving from a CFO position at VBI Vaccines.

“We welcome Jim to the Motus GI team as we grow the organization to support the commercial roll-out of Pure-Vu System. His broad experience with commercial healthcare companies will be extremely valuable as we launch the Pure-Vu System in both the in-hospital and outpatient settings, providing physicians with new options to cleanse the colon intra-procedurally to achieve visualization of the colon mucosa during colonoscopy,” CEO Mark Pomeranz said in prepared remarks.

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Researchers develop method for storing vaccines at room temp

Researchers at Ecole Polytechnique Federale de Lausanne‘s Supramolecular Nanomaterials and Interfaces Laboratory have developed methods for 3 additives to help store vaccines at room temperature. The team’s work was published in Nature Communications. 

The need to keep vaccines within a temperature range of 2-8°C contributes to low immunization-coverage rates, because shipping the medicines in an unbroken temperature-controlled supply chain is a logistical and costly endeavor in remote areas. But this team of researchers devised a way to use small quantities of nanoparticles, FDA-approved polymer, or higher amounts of sucrose to stabilize the medicines at room temperature for long periods of time.

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

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Loaded nanocarriers deliver drugs and imaging molecules to tumors

Researchers from the University of Washington developed synthetic nanocarriers to encase chemotherapy drugs and deliver them directly to the tumor site, avoiding healthy tissue. The team’s work was published in the journal Small. 

The nanocarrier is a hybrid of synthetic materials designed to allow the system to carry drugs and fluorescent particles to stain the tumor for imaging by surgeons.

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

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Cambridge Consultants develop miniature robot for cataract surgery

Tech development group Cambridge Consultants are developing the Axsis, a new, micro-sized robotic surgical unit designed for cataract surgery.

Measuring a meager 1.8 millimeters in diameter, the Axsis features 2 robotic arms which use tendon-like cables for precise movement, with each cable measuring just 110 microns in diameter, approximately the same as a human hair.

The cords are made from gel-spun polyethylene, which the company says is stronger than kevlar. The arms are designed to be controlled by 2 haptic joysticks, which use sensing algorithms to minimize human error risk.

“You can see where the robot is, see where the lens is, see where the relevant anatomy is. And by having a computer in the loop between when the surgeon’s moving their hands and the robot moving, that computer can recognize when the surgeon’s about to make a motion that can go outside and actually puncture the lens, for example, and stop that motion,” Cambridge Consultants advanced surgical systems head Chris Wagner told Reuters.

Cambridge Consultants said the Axsis system is still under production and will need several years to move from prototype to usable tool, but that the device is a showpiece for future miniaturization in surgical robotics.

“I think the fact that it’s a 1.8 millimeter diameter robot that’s operating on the size scale of the eye, it’s exciting. This just opens the door to a number of different types of procedures that you can do that previously weren’t possible,” Wagner said.

Material from Reuters was used in this report.

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France’s drugs agency freezes Carmat implants after 5th death

France’s national drugs agency said today it is ordering artificial heart maker Carmat (FRA:CXT) to freeze implantation of its devices after the death of a 5th patient last month.

The company distanced itself from the death, with chief exec Stephanie Piat stating that the artificial heart was not involved and that the last 3 implantations of the device functioned normally, according to Reuters.

The French regulatory body requested further information from Carmat following the death of the patient, who was implanted with the heart at the end of August.

The patient was the 1st of 20 scheduled to receive the hearts in a clinical trial of the devices as the company seeks regulatory approval, according to Reuters. Other patients in the trial are slated to receive their hearts in the coming weeks.

Shares in Carmat have dropped 17.7% this year, with the compay valued at approximately $211.7 million (EU €2 million).

In August, the company launched a pivotal trial of its bioprosthetic artificial heart, hoping to use the data to win CE Mark approval in the European Union.

Carmat’s 1st transplant patient, a 76-year-old man, died in March 2014, 2½ months after his operation. A 2nd patient died in May 2015, 9 months after receiving the transplant. Carmat said his death was due to a technical problem with the controls of the motor. A 3rd patient was fitted with the device in April 2015.

“The 4th patient will undergo surgery once everything has been analyzed and the engineers are able to tell me, ‘Go ahead, we’ve checked everything, everything’s fixed, the new device won’t [encounter] the same issues as the previous ones,’” Dr. Alain Carpentier, who invented the device, said at the time.

Material from Reuters was used in this report

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WhiteClouds inks partnership deal with TeraRecon, launches 3DyourScan anatomical model printing

3D-printing cloud provider WhiteClouds said today it inked a partnership deal with TeraRecon and launched the 3DyourSCAN life-size anatomical model printing service.

The newly launched 3DyourScan service is designed to produce 3D-printed anatomical models from CT or MRI scans, and will utilize the WhiteClouds “Hinge & Slice” feature, which the company claims will “provide the most granular, detailed patient-specific models available.”

Get the full story at our sister site, Medical Design & Outsourcing.

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MassDevice.com +5 | The top 5 medtech stories for November 30, 2016

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. Smart patch monitors blood, releases blood thinners to prevent clots

Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patient’s blood and release blood-thinning drugs to prevent dangerous blood clots, or thrombosis. The team’s work was published in Advanced Materials.

When blood clots disrupt the flow of blood throughout the body, the result can cause pulmonary embolism, heart attack or stroke. Conventional treatment requires patients to regularly test their blood to ensure proper dosages of blood thinners such as Heparin. Read more

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4. Moximed launches IDE trial of Atlas unicompartmental knee

California orthopedic device developer Moximed said today it enrolled the 1st patient in an FDA approved investigational device exemption trial of its next-gen Atlas unicompartmental unloading knee implant.

The Atlas is designed to treat osteoarthritis knee joint pain in patients ages 35 to 65 whose condition has not degenerated enough to require arthroplasty. The device is a joint unloader placed along the knee to absorb excess load and buy time. Read more

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3. NeuroMetrix wins CE Mark for Quell wearable pain relief device

NeuroMetrix said today it won CE Mark approval in the European Union for its Quell wearable pain relief device, now cleared as a class IIa medical device in the region.

The Waltham, Mass.-based company said that recent studies indicate that 20-40% of the adult European population suffers from chronic pain, which costs the region approximately $250 billion annually. NeuroMetrix’s Quell is designed to treat chronic pain, which can help improve sleep, mental and general health. Read more

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2. Becton Dickinson to shutter Creedmoor, N.C. plant, lay off 120

Becton Dickinson & Co. is reportedly shutting down its Creedmoor, N.C. plant and laying off the 120 workers that operate out of it, according to The News & Observer.

The facility in Creedmoor produces tubing for intravenous pumps, according to the report. The production at the facility will be consolidated to existing facilities, with assembly jobs moving to Tijuana and Nogales, Mexico, while molding work will move to Sandy, Utah. Read more

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1. Anonymous strategic investor puts another $5m into Endonovo’s Immunotronics

Endonovo Therapeutics said this week that it inked a $5 million deal with an anonymous strategic investor aimed at retiring its convertible debt, launching pre-clinical studies of its Immunotronics platform and uplisting its shares.

The Los Angeles-based company, which is developing technology it calls “Immunotronics” to stimulate liver regeneration and treat inflammatory conditions, said it plans to use the proceeds in part to buy back some $2.2 million worth of convertible debt. Its backer is the same entity that’s the lead investor in a previously announced financing worth $10 million, Endonovo said. Read more

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Report: J&J raises the stakes in Actelion pursuit

Johnson & Johnson (NYSE:JNJ) has reportedly raised its offer for Swiss biotech firm Actelion Pharmaceuticals (VTX:ATLN), pressuring the company to accept a takeover deal.

The companies have been in talks for nearly 2 months but so far have not reached a deal, according to Reuters.

The news outlet reported that Actelion wants J&J to become a major shareholder in a new entity, which would combine the Swiss group with some of J&J’s activities. But J&J is interested in a straightforward takeover.

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

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Nordisk touts Tresiba insulin injection data

Novo Nordisk (NYSE:NVO) said today that data from the Devote clinical trial indicated that its injected insulin, Tresiba, reduced the risk of severe hypoglycemia when compared to insulin glargine.

The trial enrolled more than 7,500 type 2 diabetes patients at high risk of adverse cardiovascular events and treated them for 2 years with either Tresiba or insulin glargine U100. The long term analysis sought to confirm interim data that the Denmark-based company used to support its FDA approval for Tresiba in September last year.

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

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Abbott wins CE Mark for i-Stat handheld blood tester

Abbott (NYSE:ABT) said today it won CE Mark approval in the European Union for its i-Stat Alinity handheld blood testing platform.

The i-Stat Alinity system is designed to perform a wide range of blood tests and analyses, including blood chemistries and blood markers. The company claims the device has the “largest menu of blood tests on a single device.”

“As a global leader in point of care testing, Abbott’s i-Stat Alinity builds on our rich diagnostics heritage to help healthcare providers deliver care when and where it’s needed. Whether in emergency departments, critical care settings or rural areas, i-Stat Alinity allows clinicians to make timely and informed treatment decisions that help people get back to better health,” Abbott point of care diagnostics VP Sharon Bracken said in a press release.

The device requires only 2 to 3 drops of blood, Abbott said, and can deliver results in between 2 and 10 minutes, with connectivity features to allow testing to be conducted in a variety of environments.

Features of the newly-cleared device include improved quality control, single-cartridge testing for multiple tests, wireless or wired connectivity and cloud connectivity, Abbott said.

Earlier this week, anti-trust regulators in the European Union granted conditional approval for the $25 billion merger of  Abbott and St. Jude Medical (NYSE:STJ).

The European Commission’s decision on the deal requires the divestiture of a pair of device lines: St. Jude must deal its Angio-Seal and Femoseal vascular closure assets, including a manufacturing plant in Puerto Rico, and Abbott must deal the Vado steerable sheath it bought with the acquisition of Kalila Medical earlier this year.

Happily for Abbott and St. Jude, those assets are already slated for a $1 billion sale to Japan’s Terumo (TYO:4543).

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Becton Dickinson to shutter Creedmoor, N.C. plant, lay off 120

Becton Dickinson & Co. (NYSE:BDX) is reportedly shutting down its Creedmoor, N.C. plant and laying off the 120 workers that operate out of it, according to The News & Observer.

The facility in Creedmoor produces tubing for intravenous pumps, according to the report. The production at the facility will be consolidated to existing facilities, with assembly jobs moving to Tijuana and Nogales, Mexico, while molding work will move to Sandy, Utah.

The decision to close the location was reportedly based on increasing efficiency, and not on plant performance.

“Decisions like these that affect our employees are never easy and are not taken lightly,” company spokesperson Troy Kirkpatrick told The News & Observer. “It made more sense for us to use some of our excess capacity in our other plants.”

Employees at the facility were informed of the closure in July, with layoffs taking place over 12 months beginning in April and ending in March 2018.

B.D. originally acquired the facility in its $12.2 billion purchase of CareFusion in 2014. The company employs approximately 475 individuals in North Carolina, including 215 engineering employees at its Research Triangle Park facility, according to The News & Observer report.

In September, BD said it is investing $40.4 million (EU €36 million) to expand production equipment at its Drogheda, Ireland facility, adding an additional 20 jobs.

The Franklin Lakes, N.J.-based company’s Drogheda facility produces BD PosiFlush syringes and safety components designed for insulin injection. The $40.4 million investment will allow for 2 new production lines at the plant, with the 1st manufacturing line having already commenced production.

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OCUL registers for $40m stock sale

Ocular Therapeutix (NSDQ:OCUL) is looking to raise $40 million through a public stock offering, according to a prospectus filed with the federal Securities & Exchange Commission this week.

The Bedford, Mass.-based company said it inked a controlled equity offering sales agreement with Cantor Fitzgerald & Co., and agreed to pay Cantor Fitzgerald commissions of up to 3% of the process from the sales of the shares for it services.

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

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Counterfeit prescription drug tracker raises $52m

TraceLink Inc. said yesterday that it raised $51.5 million in a Series C financing round, bringing its total raised to $77 million. The round was led by Goldman Sachs Growth Equity, joining FirstMark Capital, Volition Capital and F-Prime Capital.

TraceLink developed a cloud-based global network of manufacturers, distributors, pharmacies and healthcare professionals. The firm’s system enables any company within the pharmaceutical supply chain to track and trace authentic prescription medicines, which it says will be required by law in 50 countries by 2020.

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

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Anonymous strategic investor puts $5m into Endonovo’s Immunotronics

Endonovo Therapeutics (OTC:ENDV) said this week that it inked a $5 million deal with an anonymous strategic investor aimed at retiring its convertible debt, launching pre-clinical studies of its Immunotronics platform and uplisting its shares.

The Los Angeles-based company, which is developing technology it calls “Immunotronics” to stimulate liver regeneration and treat inflammatory conditions, said it plans to use the proceeds in part to buy back some $2.2 million worth of convertible debt. Its backer is the same entity that’s the lead investor in a previously announced financing worth $10 million, Endonovo said.

The latest $5 million fund is also slated for the development of Immunotronics treatments for vascular conditions, the company said.

“We are very excited to work with a strategic investor, who recognizes the value of the company and the significant potential of our non-invasive technology in the treatment of several very large unmet clinical needs,” chairman & CEO Alan Collier said in prepared remarks. “It is very important that we buy back all outstanding convertible notes in order to prevent dilution and preserve shareholder value. We believe that our stock is considerably undervalued.

“This round of financing allows us to fund our the development of portfolio of treatments targeting vascular diseases and ischemic injuries and strengthens our financial position to uplist our common stock onto a national stock exchange in the first half of next year,” Collier said.

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Developing contextual tools for interpreting pediatric brain scans

Radiologists who can tune in to the nuances of brain scans in children are a pretty rarified group. Only about 3 percent of U.S. radiologists, some 800 to 900 physicians, practice in pediatrics. Those specifically trained in pediatric neuroradiology are even scarcer.

To a less trained eye, normal developmental changes in a child’s brain may be misinterpreted as abnormal on MRI. Conversely, a complex brain disorder can sometimes appear normal. That’s especially true when the abnormality affects both sides of the brain equally (see sidebar).

It can be hard to find the cause of a child’s developmental delay without a proper read. “Pediatric brain scans of children under age 4 can be particularly tricky to read because the brain is rapidly developing during this period,” says Sanjay Prabhu, MBBS, a pediatric neuroradiologist at Boston Children’s Hospital. “If you’re looking at adult scans all the time, it’s incredibly difficult to transition to pediatric scans and understand what is considered ‘normal’ and ‘abnormal.’ Clinicians often wonder, ‘Should I repeat the scan? Should I send the patient to a specialist?’”

Decision support for brain scans in children

Prabhu and his colleagues are often asked to review brain scans taken at other hospitals. Frequently, they revise a prior diagnosis or make a first-time diagnosis for a child, ending a long and stressful diagnostic odyssey. Could they somehow share their expertise with a much wider group of physicians?

Today, Boston Children’s and GE Healthcare announced a collaboration to develop and commercialize digital diagnostic solutions. Their first project is a decision support platform aimed at improving diagnostic accuracy in pediatric brain MRI scans.

Read the full post on Vector: Real-time contextual information could help doctors interpret children’s brain scans

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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Moximed launches IDE trial of Atlas unicompartmental knee

California orthopedic device developer Moximed said today it enrolled the 1st patient in an FDA approved investigational device exemption trial of its next-gen Atlas unicompartmental unloading knee implant.

The Atlas is designed to treat osteoarthritis knee joint pain in patients ages 35 to 65 whose condition has not degenerated enough to require arthroplasty. The device is a joint unloader placed along the knee to absorb excess load and buy time.

The cylindrical shock absorber component is about as long as a standard house key and has the diameter of a pencil, and the bases that attach to the bone have a footprint a bit larger than a quarter. Once the osteoarthritis becomes too severe, Atlas can be taken out to make room for a full knee replacement as needed.

“The Atlas System provides the same 30 lbs of joint unloading with a significantly smaller implant and anatomically-guided surgical technique. Patients intuitively understand the concept of a shock absorber and are excited about a procedure that preserves their own anatomy without the bone cuts associated with joint replacement. I am looking forward to enrolling my first patients in the Atlas study,” principal US investigator Dr. Jack Farr of Indiana’s OrthoIndy Cartilage Restoration Center said in a prepared release.

“I’m pleased to treat the 1st patient in the Atlas IDE study. I see in my practice a tremendous number of younger, early OA patients who are seeking an alternative to arthroplasty that will allow them to maintain a highly active lifestyle. Load distribution plays an important role in early osteoarthritis, and these patients could potentially benefit from a joint unloading procedure,” Dr. Andreas Gomoll of Harvard Medical School said in prepared remarks.

“Beginning a US study with the Atlas System is a noteworthy accomplishment for the company. Following on the maturing data from the pivotal study of our previous generation device, we are now excited to study the Atlas System for US patients in the clinical setting. We anticipate the Atlas IDE study will reproduce the positive outcomes and safety data presented from the first international studies of the device,” CEO Kevin Sidow said in a prepared statement.

The company won CE Mark approval in the European Union in December last year.

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West expands CMO facilities in Ireland

West Pharmaceutical Services (NYSE:WST) said today that it finished a 60,000 square foot expansion of its contract manufacturing facility near Mulhuddart, County Dublin in Ireland. The expansion is a response to customer demand for medical device manufacturing, especially in the area of diabetes, the company reported.

West anticipates 100 new jobs will be added to the business over 5 years because of the expansion. Additional capacity in Dublin will grow the company’s medical device contract manufacturing business, focusing on molding and assembly solutions for the production of medical devices like auto-injectors and glucose monitoring systems.

The company also said that its contract manufacturing business, which was formerly known as The Tech Group, will align with the West brand.

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

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Smart patch monitors blood, releases blood thinners to prevent clots

Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patient’s blood and release blood-thinning drugs to prevent dangerous blood clots, or thrombosis. The team’s work was published in Advanced Materials.

When blood clots disrupt the flow of blood throughout the body, the result can cause pulmonary embolism, heart attack or stroke. Conventional treatment requires patients to regularly test their blood to ensure proper dosages of blood thinners such as Heparin. I

f a patient uses too small a dose, it may not prevent a relapse of thrombosis. On the contrary, too large a dose can cause spontaneous hemorrhaging.

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

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Celgene invests in GNS

Celgene (NSDQ:CELG) said this week that it has made another investment in GNS Healthcare and inked a deal with the bioanalytics firm for its “Reverse Engineering and Forward Simulation” software.

GNS’s software analyzes health data, including electronic health records, pharmacy claims and genomic sequences, and uses machine learning to answer questions in healthcare.

The multi-year agreement with Celgene involves several GNS employees working in Celgene facilities to help operate the software. “We were already working with them in the past, but this is now really deepening and broadening the relationship,” GNS co-founder and CEO Colin Hill told Xconomy.

Summit, N.J.-based Celgene also made a 2nd equity investment in GNS. Although the amount of Celgene’s investment was not disclosed, an SEC filing showed that GNS raised a total of $4 million in equity funding. Last year, Celgene participated in a $10 million Series C round for the company.

GNS told Xconomy that it plans to use the new funding to invest in development and gain access to more health data. “It’s really about continuing the investments that we’ve been making for a long time,” Hill told the news outlet. “As the industry is growing, as the need for our products and services is growing, we’re investing in supporting that because we really see a huge market for what we’re providing.”

In May this year, Celgene inked a collaborative deal with TriNetX to develop advanced clinical trial design for Celgene’s next-gen therapeutic programs. According to the agreement, Celgene will be able to access medical data from electronic medical records through TriNetX’s proprietary network of healthcare institutions.

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Philips launches Intellispace Portal 9.0 radiological visual analysis & quantification platform

Royal Philips (NYSE:PHG) said today it launched its IntelliSpace Portal 9.0, the most recent iteration of its radiological visual analysis and quantification platform.

The new version of the platform utilizes machine learning to aid operating radiologists in detecting, diagnosing and following-up on treatment for diseases and traumas, such as brain juries and neurological disorders including dementia, stroke, amyotrophic lateral sclerosis and multiple sclerosis.

“As the rates of dementia and neurodegeneration rise, neuroradiologists need advanced tools to help referring physicians treat these challenging cases. IntelliSpace Portal 9.0 offers a comprehensive set of robust tools so neuroradiologists can quantify disease expediently,” Dr. Leo Wolansky of University Hospitals Cleveland Medical Center said in a prepared release.

The new version of the IntelliSpace platform also includes longitudinal brain imaging to support the evaluation of neurological disorders over time, to aid in the monitoring of disease progression. The upgraded platform also includes the NeuroQuant measurement application for quantifying brain volume loss, Philips said.

“Radiology has a unique ability to influence and improve outcomes, and intelligent tools enable us to empower radiologists with the right information. With advances in machine learning, IntelliSpace Portal 9.0 will now be able to continually learn the usage patterns of users to enhance the important daily functions of a radiologist such as pre-preprocessing of images, encouraging faster and more streamlined diagnosis,” Philips Healthcare IT GM Yair Briman said in a press release.

Earlier this month, Philips launched its IQon spectral CT in Canada, touting it as the world’s 1st and only spectral CT scanner designed specifically for spectral imaging.

The company’s newly released device is designed to provide multiple layers of retrospective, diagnostic data through a single, low-dose scan.

Philips said its IQon spectral CT adds spectral resoltuion to traditional CT scans through a dual-layer spectral detector designed to identify photons of high energy and low energy simultaneously.

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NeuroMetrix wins CE Mark for Quell wearable pain relief device

NeuroMetrix (NSDQ:NURO) said today it won CE Mark approval in the European Union for its Quell wearable pain relief device, now cleared as a class IIa medical device in the region.

The Waltham, Mass.-based company said that recent studies indicate that 20-40% of the adult European population suffers from chronic pain, which costs the region approximately $250 billion annually. NeuroMetrix’s Quell is designed to treat chronic pain, which can help improve sleep, mental and general health.

“Europe is the natural market for initial international expansion of Quell sales. Today we are focused on North America; however, our longer term strategy is to make Quell available in all markets with a high prevalence of chronic pain. Now that we have CE Certification, we will accelerate partnership and distribution discussions that will position us for market entry in 2017. We are pleased to have gained certification making Quell available in Europe,” CEO Dr. Shai Gozani said in a press release.

In September, NeuroMetrix said it launched a pilot study of its Quell wearable pain relief device for treating patients with fibromyalgia. NeuroMetrix said it is partnering with the Synovation medical group to carry out the study.

In June, NeuroMetrix said it is seeking CE Mark approval in the European Union for over-the-counter clearance for its Quell wearable chronic pain relief system. The company touted recent studies which indicate that 20-40% of the adult European population suffer fron chronic pain, with an annual financial cost exceeding $250 billion.

Earlier in June, NeuroMetrix said it closed a $21.3 million round of funding through the private placement of preferred stock and warrants to support its Quell device.

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MassDevice.com +5 | The top 5 medtech stories for November 29, 2016

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. Medtronic launches Integrated Health Solutions at University Hospitals

Medtronic said today it launched its Integrated Health Solutions, which aims to improve delivery of care and patient experience, inking the 1st agreement of its kind for the service with the University Hospitals healthcare system.

The Fridley, Minn.-based company said it will work with UH to implement operational models designed to optimize workflow and improve operational efficiency for catheterization and electrophysiology labs at the University Hospitals Cleveland Medical Center. Read more

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4. FDA dings hospitals over medical device adverse event reporting failures

The FDA today released a list of hospitals tagged over inadequate medical device reporting issues, naming 17 in a review covering the period between April, 2016 and now.

Included on the list are Los Angeles’ Cedars-Sinai Medical Center, Boston’s Brigham and Woman’s Hospital and Massachusetts General Hospital, UCLA’s Ronald Reagan Medical Center and Pittsburgh, Penn.’s Allegheny General Hospital. Read more

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3. Medtronic wins EU nod for less-invasive HVAD implant procedure

Medtronic said today it won CE Mark approval in the European Union for a less-invasive implant procedure for the HVAD system left ventricular assist device it acquired along with HeartWare in August.

The new implantation procedure uses a smaller incision than the previously cleared procedure, Fridley, Minn.-based Medtronic said, potentially lessening bleeding and related blood transfusions. Read more

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2. Back to court: Nevro files new patent infringement suit against Boston Scientific

Nevro Corp. said today it filed a patent infringement suit against Boston Scientific, asserting that the company infringed on patents related to its Senza and HF10 spinal cord stimulation systems.

The suit, filed in the United States District Court for the Northern District of California, is seeking preliminary and permanent injunctive relief against further infringement, as well as damages and attorneys fees. Read more

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1. House to vote this week on 21st Century Cures Act

The U.S. House of Representatives is set to vote this week on the 21st Century Cures Act, which looks to speed up FDA approval of both new drugs and devices, as well as provide a boost in funding for medical research.

Leaders of the House and Senate said late on Friday they worked out a deal to pass the legislation, according to Stat News, though a final version of the bill is still in negotiation with Senate democrats. Read more

The post MassDevice.com +5 | The top 5 medtech stories for November 29, 2016 appeared first on MassDevice.

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Oramed touts phase Ib data for type 2 diabetes capsule

Oramed Pharmaceuticals (NSDQ:ORMP) said today that it finished a phase Ib study of its oral GLP-1 analog capsule for type 2 diabetes.

Glucagon-like peptide-1 (GLP-1) is a hormone that stimulates the pancreas to secrete insulin. Exenatide, a GLP-1 analog, is available on the market as an injection for patients with type 2 diabetes. The analog stimulates insulin release at increased glucose levels and can result in reduced food intake, along with weight loss.

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

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Windtree touts inhaled therapy for infants with respiratory distress syndrome

Windtree Therapeutics (NSDQ:WINT) today released data from a phase IIa trial evaluating its inhaled Aerosurf lucinactant designed for premature infants with respiratory distress syndrome.

Results from the trial were presented at the 6th International Congress of European Neonatal and Perinatal Societies in Valencia, Spain.

Premature babies often lack adequate surfactant – a naturally occurring substance that reduces the surface tension of fluids in the lungs and helps to enable stable breathing. To make up for an insufficient supply of surfactant, doctors use lucinactant replacement therapy in a liquid formulation immediately after birth in order to help the child breathe.

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

 

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Micell begins MiStent clinical trial in Japan

Micell Technologies said today that it began its Dessolve J randomized, double-blind study comparing its MiStent SES sirolimus eluting absorbable polymer coronary stent to the Xience V everolimus eluting coronary stent in patients with coronary artery disease.

The Durham, N.C.-based company touts its device as a bare-metal stent coated in crystalline drug, sirolimus, and an absorbable polymer, with the goal of providing local drug delivery.

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

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Medtronic launches Integrated Health Solutions at University Hospitals

Medtronic (NYSE:MDT) said today it launched its Integrated Health Solutions, which aims to improve delivery of care and patient experience, inking the 1st agreement of its kind for the service with the University Hospitals healthcare system.

The Fridley, Minn.-based company said it will work with UH to implement operational models designed to optimize workflow and improve operational efficiency for catheterization and electrophysiology labs at the University Hospitals Cleveland Medical Center.

“Our collaboration with Medtronic gives us a unique opportunity to learn from their international best practices in inventory management and scheduling optimization. We are excited to embed their expertise into our clinical operations, allowing our clinical staff to focus on providing the highest level of cardiovascular care for our patients,” UH COO Dr. Jeffrey Peters said in prepared remarks.

Medtronic said the agreement signals the expansion of its managed services offerings to U.S. health systems.

“Our Integrated Health Solutions business was formed as part of a commitment to advance healthcare delivery in more cost-effective ways. Our goal in collaborating with UH is to enhance patient care and system efficiency through the unique combination of operational insights, data, medical technology, and services. Medtronic has more than 65 years of experience to bring to the table, and we intend to be a close associate in implementing innovative solutions along the way,” Medtronic Americas region prez Mike Genau said in a press release.

Yesterday, Medtronic and German medical digital integration group S-Cape revealed updated, fully connected operating rooms at a Spanish hospital.

The Andalusia region public healthcare service invested $1.27 million (EU €1.2 million) in creating a new operating room at Seville’s University Hospital Virgen Del Rocío, designed specifically for general and digestive surgery, according to Fridley, Minn.-based Medtronic.

The company said it partnered with the hospital to help develop the new operating room, the company said. The upgrade brings the total number of operating rooms at the hospital to 5, with the latest being equipped with connected technologies.

 

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Cynosure wins Chinese FDA nod for Icon aesthetic system

Cynosure (NSDQ:CYNO) said today it won Chinese FDA clearance for its Icon aesthetic system, which is now cleared for multiple aesthetic indications.

The system is now cleared in China for facial vessel and pigment clearance, wrinkle reduction, hair removal and scar and stretch mark treatment, the Westford, Mass.-based company said.

“Cynosure was the 1st U.S. aesthetic laser company to establish a wholly owned subsidiary in China more than 10 years ago, and we continue to expand our competitive position in that country – and the entire Asia Pacific region – as part of our international growth strategy. Today, China is our largest subsidiary in the world. Gaining CFDA approval to market Icon there is another milestone as we strive to grow our APAC business at a pace ahead of the overall market. With strong customer relationships, an established direct sales force, and the rapid growth of medical aesthetics in China, we believe we are positioned to achieve that objective,” prez & CEO Michael Davin said in a press release.

The company said it plans to begin offering the Icon system in China during the 4th quarter of 2016.

In May, Cynosure said it won FDA 510(k) clearance for its 1064 nm PicoSure laser delivery system designed for tattoo removal.

The next-gen laser delivery system has improved multi-wavelength laser technology designed to remove the “full color spectrum of tattoo inks” in less treatments than previous versions, the Westford, Mass.-based company said.

The post Cynosure wins Chinese FDA nod for Icon aesthetic system appeared first on MassDevice.

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Tests to begin for HIV therapy injections, long-acting implants

Drugs from companies such as GlaxoSmithKline (NYSE:GSK), Gilead Sciences (NSDQ:GILD) and Merck (NYSE:MRK) are reportedly being considered for large-scale trials evaluating injectable HIV prevention therapies.

Eventually, researchers hope to produce matchstick-sized implants that could provide year-long protection to vulnerable populations.

Foster City, Calif.-based Gilead has a once-daily pill, Truvada, which prevents HIV infection during sex. Pre-exposure prophylaxis, also known as PrEP, can lessen the risk of catching the virus by more than 90% if the pill is taken regularly. Many patients, however, do not adhere to the regimen and some women reported in trials in Africa that they were reluctant to have HIV tablets in their houses because of the virus’s stigma.

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

The post Tests to begin for HIV therapy injections, long-acting implants appeared first on MassDevice.

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Medtronic wins EU nod for less-invasive HVAD implant procedure

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a less-invasive implant procedure for the HVAD system left ventricular assist device it acquired along with HeartWare in August.

The new implantation procedure uses a smaller incision than the previously cleared procedure, Fridley, Minn.-based Medtronic said, potentially lessening bleeding and related blood transfusions.

The newly cleared procedure could potentially reduce the development of right heart failure and could lead to shorter hospital stays, along with allowing for the area around the heart to remain largely intact to potentially preserve the sternum for future procedures or heart transplants, the company said.

“The HVAD System’s small size makes it well-suited for routine thoracotomy implantation. This less-invasive implant procedure potentially enables faster patient recovery compared to the traditional approach, which may help improve patient outcomes,” Dr. Jan Schmitto of Germany’s Hannover Medical School, who helped develop the new procedure, said in prepared remarks.

The company said it is currently performing an ongoing study of the thoracotomy HVAD procedure in Canada and the U.S., where it does not currently have approval.

“The HVAD System is the only full-support, centrifugal LVAD approved in Europe for thoracotomy implantation, providing clinicians with greater freedom to choose the best surgical technique for each patient. CE Mark for the thoracotomy procedure is a testament to the HVAD system’s flexibility and versatility, and may enable more patients to receive the life-sustaining benefit of the device for the treatment of advanced heart failure,” VP and Medtronic HF biz GM Dr. David Steinhaus said in a press release.

HeartWare is currently engaged in 2 ongoing recalls of its HVAD devices, which it originally announced in September. Earlier this month, the FDA released updated information on the Class I recalls, which affect a total of 4,669 units.

The 1st recall is over issues with loose power connectors, which may cause the rear portion of the pump’s driveline connector to become separated from the front portion. A loose connector could allow moisture to entire the controller and cause corrosion, which could cause electrical issues, reduced speaker volume and connection failures.

The 2nd recall is related to design flaws in the driveline connector of the device which connects the HVAD’s pump to the external controller and power source. The flaw could cause contamination of the driveline which can result in fluid and material entering the pump and causing electrical issues or pump stops.

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Back to court: Nevro files new patent infringement suit against Boston Scientific

Nevro Corp. (NYSE:NVRO) said today it filed a patent infringement suit against Boston Scientific (NYSE:BSX), asserting that the company infringed on patents related to its Senza and HF10 spinal cord stimulation systems.

The suit, filed in the United States District Court for the Northern District of California, is seeking preliminary and permanent injunctive relief against further infringement, as well as damages and attorneys fees.

One of the patents in question, no. 8,359,102 was the target of 2 petitions for inter partes review as filed by Boston Scientific last November, and part of a spat which Nevro beat late last year.

The Patent Trial and Appeals Board of the U.S. Patent and Trademark Office declined the reviews, Nevro claims, saying that “Boston Scientific failed to establish a reasonable likelihood of showing that even one of the challenged claims of the ‘102 patent was invalid.”

“Nevro was founded in 2006 to develop meaningful advances in the treatment of chronic pain to improve patients’ lives. Intellectual property is the basis for innovation in health sciences given the long development timelines, investment, and risk required to bring meaningful advances to market.  We are committed to ensuring continued innovation in health sciences by protecting our intellectual property,” Nevro prez & CEO Rami Elghandour said in a press release.

The new suit follows a Nevro victory in a previous spat between the 2 last December, where Nevro beat a pair of challenges to 1 of its patents by Boston Scientific after the U.S. Patent & Trademark office declined to institute inter partes reviews.

Nevro’s Senza device, which won pre-market approval from the FDA in May, is designed to deliver up to 10,000Hz to the spinal cord, allowing it to avoid the tingling sensation known as paresthesia that bothers some patients. The FDA allowed the company to label the device as superior to other spinal cord stimulators, including some made by Boston Scientific.

The patent, no. 8,359,102, covers “Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods.” Boston asked the Patent Office to review the patent a week after the FDA approved Senza; in a pair of Nov. 30 decisions, the PTO’s Patent Trial & Appeal Board found that Boston Scientific “has not demonstrated a reasonable likelihood of prevailing on its assertion.”

The decision was “an outright victory” for Redwood City, Calif.-based Nevro, according to Leerink Partners analyst Danielle Antalffy, who predicted the win in September, and “will likely make it increasingly difficult for BSX to come to market with a high frequency device without another workaround of NVRO’s patents.”

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Russian regulators expand list of implantable medical devices

By Stewart Eisenhart, Emergo Group

Russia’s medical device market regulator Roszdravnadzor has updated its list of products that qualify as implantable medical devices with 160 additions.

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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House to vote this week on 21st Century Cures Act

The U.S. House of Representatives is set to vote this week on the 21st Century Cures Act, which looks to speed up FDA approval of both new drugs and devices, as well as provide a boost in funding for medical research.

Leaders of the House and Senate said late on Friday they worked out a deal to pass the legislation, according to Stat News, though a final version of the bill is still in negotiation with Senate democrats.

The House will vote on the approximately $6.3 billion legislation, which would provide $500 million for the FDA and $1 billion to battling the opioid epidemic. The legislation also includes $4.8 billion to support 3 Obama administration research programs over 10 years – VP Biden’s cancer moonshot, the BRAIN Initiative and the Precision Medicine Initiative.

Much of the bill focuses on the FDA, including provisions to establish an expedited review for breakthrough devices, hastening reviews of drug-device combos and increasing patient participation in drug approvals.

The bill would also require the FDA to evaluate the use of “real world” evidence to support new uses and post-approval studies for previously approved drugs, as opposed to the gold standard of randomized clinical trials.

Medtech industry lobby group Advamed, which allegedly held regular, private meetings to help write the bill, posted a release supporting the passing of the Act.

“The package includes a number of important improvements to FDA’s medical device premarket program designed to increase the efficiency, predictability and transparency of the agency’s review process. The most significant of these builds on initiatives already underway within FDA to help create an expedited pathway for breakthrough medical technologies – those that offer the best hope for patients with life-threatening or irreversibly debilitating diseases or conditions who have no or limited alternative treatment options,” AdvaMed wrote in a press release. “We urge Congress to take action of this important legislation as soon as possible for the benefit of patients everywhere.”

The bill, which was developed by the House Energy & Commercial Committee, passed the U.S. House of Representatives 344-77 last July.

The 21st Century Claims Act has been highly praised and criticized since it was brought forth. Last July, the New York Times published op-eds which slammed and praised the Cures Act, with sides claiming it would severely weaken, or transversely strengthen, the FDA.

Last December, the act drew criticism from consumer watchdogs and FDA experts after it was revealed that there was an unprecedented level of collaboration between the federal safety watchdog and the industry it regulates.

FDA documents released late last year showed collaboration between the FDA and the medical lobbying group, AdvaMed, even while Congress was holding public roundtables about the bill, according to BloombergBusiness.

The FDA’s Center for Devices & Radiological Health and AdvaMed “worked together on the proposed language for most of the device provisions in” the Cures Act, according to an FDA memo from an Aug. 7 meeting attended by Dr. Robert Califf, the cardiologist nominated by who President Barack Obama to be the FDA’s new commissioner. Executives from Johnson & Johnson(NYSE:JNJ) and St. Jude Medical (NYSE:STJ) also attended, BloombergBusiness reported.

“For the Senate version of 21st Century Cures, CDRH is currently working with AdvaMed to refine their regulatory strategy in a way that is agreeable to both parties,” according to the August meeting memo.

AdvaMed spokeswoman Wanda Moebius told the news service that the creation of the 21st Century Cures bill was a “very open and inclusive process collecting input across the health care community via written statements, town hall meetings, roundtables and hearings.”

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Bovie Medical closes $6m offering

Bovie Medical (NYSE:BVX) today closed a $6 million funding round, floating 1.63 million shares of stock at $4 per share.

The round also included a secondary offering of 1.63 million shares made by certain stockholders of the company, Clearwater, Fla.-based Bovie Medical said in an SEC filing.

Net proceeds, after deducting discounts, commissions and expenses from the primary offering are expected to be $6 million, while all proceeds raised by the secondary offering will go to the selling stockholders.

The raised funds are on target with what the company was expecting when it priced the round earlier this month, expecting to bring in $12 million total to support expanding sales and marketing and R&D.

The offering includes a 30-day underwriters option to purchase an additional 450,000 shares of common stock, according to a press release.

Funds from the round will support the expansion of sales and marketing and research and development, as well as to conduct clinical trials and for general working capital and corporate purposes, the company said.

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Researchers develop bioresorbable capsule for treating hemophilia

Researchers from the Cockrell School of Engineering at the University of Texas at Austin have developed a biodegradable capsule to deliver a protein therapy for hemophilia. The research, published in the International Journal of Pharmaceutics, could provide a cheaper, less painful alternative to injections or infusions.

The capsule contains micro and nanoparticles which carry a protein therapy to treat hemophilia B. The disease is caused by a missing or defective factor IX, a clotting protein, in the blood. Access to the protein therapy is limited due to its cost and the complications brought on by needle-based drug delivery.

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

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S-Cape, Medtronic reveal new connected ORs in Spain

Medtronic (NYSE:MDT) and German medical digital integration group S-Cape revealed updated, fully connected operating rooms at a Spanish hospital today.

The Andalusia region public healthcare service invested $1.27 million (EU €1.2 million) in creating a new operating room at Seville’s University Hospital Virgen Del Rocío, designed specifically for general and digestive surgery, according to Fridley, Minn.-based Medtronic.

The company said it partnered with the hospital to help develop the new operating room, the company said. The upgrade brings the total number of operating rooms at the hospital to 5, with the latest being equipped with connected technologies.

Other operating rooms were updated with features including automated work flows, advanced visualization capabilities and procedure recording, the companies said. Monitors and connected multimedia rooms were also added to allow for remote viewing and streaming of procedures to students, according to Medtronic.

Earlier this month, Medtronic said it joined Masimo (NSDQ:MASI) CEO Joe Kiani’s Patient Safety Movement Foundation with a $5 million, 5-year commitment.

By joining the program, Medtronic will provide $5 million over 5 years and share anonymized data from its medical devices to help develop analytic programs to help improve patient safety, according to a Patient Safety Movement Foundation release.

In addition, Medtronic CEO Omar Ishrak is slated to join the Patient Safety Movement Foundation’s board of directors.

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