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Articles from 2016 In October

CDRH's Shuren Extols Victories of Flexible Regulatory Approach

CDRH's Shuren Extols Victories of Flexible Regulatory Approach

During a State of the Union lecture, CDRH director Jeffrey Shuren highlighted early wins of FDA's shift toward postmarket surveillance, novel approaches to evidence generation, and focus on patient inputs.

Shuren discusses FDA regulatory priorities with other panelists at the TCT Conference.

CDRH's focus on its strategic priorities is already yielding fruit in the form of faster, more frequent device approvals and increased patient access to new technologies, according to Jeffrey Shuren, MD, JD, director of CDRH. Among the initial victories: an expanded indication for transcatheter aortic valve replacement (TAVR) therapy and approval of a first generation artificial pancreas.

Shuren made the comments during his FDA/CDRH State of the Union lecture in front of an audience at the FDA Town Hall Meeting held during the Transcatheter Cardiovascular Therapeutics conference in Washington, DC on October 31.  

In 2014-2015, CDRH's strategic priorities included improving the clinical trial system and finding a way to shift some premarket data collection to postmarket collection. As part of that, the Center created the Expedited Access Pathway (EAP) Program for breakthrough devices, encouraged more device sponsors to take part in early feasibility studies with the United States, and put a more flexible benefit-risk model in place.

Learn about "FDA Regulations Impacting Connected Health Devices and IoT" at BIOMEDevice San Jose, December 7-8.

Those moves paid off with more U.S. early feasibility studies, a large reduction in the median time it takes to receive IDE full approval, and in 2015, the highest number of IDEs approved in the first cycle in any year since 2002. One of the first devices in the early feasibility pilot program, the Angel Catheter from Bio2 Medical, received FDA 510(k) clearance in August 2016. Of 47 requests for EAP designation since the program started in April 2015, 23 requests were granted and 11 IDEs have already been received, Shuren said.

The Strategic Priorities for 2014-2015 naturally progressed in to the 2016-2017 Strategic Priorities, which include partnering with patients and creating a National Evaluation System for health Technology (NEST)

"To truly understand the benefits-risk profile of a device, you need to study it in the wild . . . The challenge is, although that data is collected all the time, a massive inefficiency is that we can't make great use of it," Shuren said. NEST is being designed to make better use of real-world clinical data.

Ideally, NEST will be able to reduce the time and cost of gathering real-world data and making it more valuable and accessible to stakeholders, Shuren said. In September 2016, the Medical Device Innovation Consortium (MDIC) was selected to establish and operate the Coordinating Center for NEST. Shuren described NEST as using a neural network approach to optimize data sharing and answer research questions quickly: "Therefore, NEST really becomes a way of activating different kinds of networks depending upon the question that needs to be addressed."

Shuren was quick to point out that FDA is already using real-world data for the premarket and postmarket settings, such as labeling indications expansions using the Transcatheter Valve Therapy registry, use of registry data as a control for single-arm trials, and databases used to evaluate in vitro diagnostics. What's more, some companies have begun "nesting" postmarket trials and registries and have found the approach saves 40-60% on costs, he noted.

The use of real-world data has made a difference. In 2015, FDA approved the most novel devices of any year since 2003 and the agency has also been "on par" with other countries in approving early feasibility studies for transcatheter mitral valve replacement devices, Shuren said. He also pointed to the fact that while the original FDA approval of TAVR trailed Europe by more than four years, the recent expanded indication into intermediate risk patients was granted in the United States and in Europe several days apart. Edwards Lifesciences' Sapien 3 received FDA approval for the intermediate risk indication on August 18 and received CE Mark for the expansion on September 19.

"We recently approved the Medtronic 670G hybrid closed-loop system for Type 1 diabetics, what some have called first generation artificial pancreas. We're not just the first one in the U.S. This was the first one in the world," Shuren said, adding that it "came on the market three years earlier than the company originally intended to have it in."

More reliance on real-world data and prioritization of patient access has meant that the "inflection point to come to market has now changed, [it's] much more fluid," Shuren said.

Which Spine Robot Will Dominate?

Which Spine Robot Will Dominate?

Surgical robotic systems took center stage at the North American Spine Society meeting last week. Here's analysts' take on the offerings from Zimmer Biomet, Mazor Robotics, and Globus Medical.

Jamie Hartford

Mazor Robotics's Mazor X system launched at the NASS annual meeting last week.

Surgical robots are used in only about one in 20 spine procedures today, but adoption could grow rapidly according to a recent survey by RBC Capital Markets. U.S. spine surgeons expect that rate to double over the next year, and a decade from now more than one in four spine surgeries could be performed using a surgical robotic system.

Three main players--Mazor Robotics (a finalist for 2016 Medtech Company of the Year), Zimmer Biomet, and Globus Medical--are vying for that market. So which one will come out on top?

Don't miss the BIOMEDevice San Jose conference and expo, December 7 & 8, 2016.

Mazor, it seems, is the favorite--at least for now. The Israel-based company officially launched its third-generation platform, Mazor X, last week at the annual meeting of the North American Spine Society in Boston, and some analysts have already put down their chips.

"This is an obvious statement but [Mazor Robotics] has the clear lead in the field with the most placed systems by far," Barclay's analyst Matthew Taylor wrote in an October 27 research note.

After 15 years in the surgical robotics space, Mazor has more than 131 systems installed, according to Taylor, while Zimmer Biomet's Rosa, which it took on upon acquiring the French firm Medtech in July, is up and running in only a handful of locations. Audubon, PA-based Globus is still awaiting FDA clearance for its Excelsius system in the United States, which it expects in early to mid 2017.

Mazor lengthened its lead with three preorders for the Mazor X system in the quarter ended September 30 and three additional orders the day after its launch, according to the company. The system offers benefits including preoperative planning, automated alignment calculations, intraoperative guidance and verification, and measurement capabilities to track procedures times, demographics, and more.

While it may be dwarfed by its much larger competitors, Mazor has Medtronic's heft behind it. In May, the Ireland-based device maker committed to copromotion, codevelopment, and possible exclusive distribution of Mazor products, and is ponying up a three-step equity investment.

"Thus far, [Mazor] has had hundreds of [Medtronic] sales reps and surgeons coming in for training labs," Taylor wrote.

In the future, the Mazor X could benefit from integration with Medtronic's imaging technology and Medtronic implants could come preloaded in the system, although it will remain open.

When it comes to clinical data, Mazor also has an edge.

"At this stage, for Rosa, there have only been a few papers from a single center that did show increases in accuracy and the ability to do more [minimally invasive surgery] procedures, and [Globus's] product has been used only in the cadaver lab," Taylor wrote, adding that reports on the progress of Mazor's trials "sound positive." Data shared in July showed the company's Renaissance technology resulted in superior outcomes when compared with fluoro-guided minimally invasive surgery, freehand minimally invasive surgery, and freehand open surgery.

But, Globus's Excelsius system, which was shown as a prototype at NASS, is generating buzz, too. Like the Mazor X, Excelsius will be open, although Globus implants will be preloaded and other companies' will require a software update. The company is hanging its hat on the system's ease of use and flexibility, according to Taylor, who reported "a fair amount of interest" in it at the Globus booth at the NASS show. Leerink analyst Richard Newitter wrote in an October 30 research note that surgeons at the NASS meeting were "very interested in trialing" the Excelsius.   

Warsaw, IN-based Zimmer Biomet, however, might have some catching up to do. There was "barely any enthusiasm" for the Rosa system, Newitter noted, although he conceded that the Zimmer Biomet-Medtech deal only recently closed and the Rosa system may not yet be ready for a full-scale launch. He predicted Mazor will remain the top dog in spine robotics--at least until other players join the fray.

"It's unclear what specific 'more sophisticated' robotic initiatives might be in the works (if anything) for [NuVasive and Johnson & Johnson] . . . but we do expect [Stryker] will eventually adapt MAKO to spine in some capacity down the road," Newitter wrote.

Jamie Hartford is MD+DI's editor-in-chief and serves as director of content for medtech brands in UBM's Advanced Manufacturing Group. Reach her at [email protected]

The Promise of Exoskeletons

ReWalk's robotic exoskeleton transformed the life of architect Robert Woo, who was paralyzed from the chest down after a construction accident.

Qmed Staff

How much could robotic exoskeletons better the lives of people with paralyzed legs? There's a great example to be had in one of the latest episodes of Freethink Media's Superhuman series. (Check out other episodes here.

Finding out about ReWalk's robotic exoskeleton was a "glimmer of hope" for Robert Woo, an architect in Toronto and New York who was paralyzed from the chest down.

"Seeing the videos actually happening and seeing someone who is paralyzed actually walking now ... not science fiction ... that excited me. That gave me a sense of purpose in life," Woo said. 

Depression turned to excitement as he liberated himself from his wheelchair, a device that has been around for centuries. "I'm very fortunate to have been one of the early people to try it," Woo says. 

Woo has even made design suggestions on how to improve ReWalk. "Like any new technology, when it first comes out the price is quite high. The more people purchase it, the demand will start growing and then the price will go down," Woo says. 

He dreams of the day when the paralyzed will be able to wear exoskeletons under their clothes and walk like anyone else. 

Discover more about connected medical device innovation at BIOMEDevice San Jose, December 7-8, 2016.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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St. Jude Sold Old ICDs After Battery Fix

The company says it would have recalled them earlier if it had known of the danger.

Nancy Crotti

St Jude Medical Fortify VR

After learning of battery problems with thousands of its implantable cardioverter defibrillators, St. Jude Medical continued to sell outdated versions of the devices for 17 months, according to a report in the Star Tribune of Minneapolis

The company recently recalled the devices, whose batteries can run out within 24 hours of the low-battery alert, according to a company statement. Two deaths have been reported. St. Jude called the early battery depletion a "rare occurrence" (0.21%) with the ICD and CRT-D devices, which were manufactured before May 23, 2015.

The actual number of devices with premature battery depletion is unknown, according to FDA and St. Jude Medical, but a total of 349,852 affected devices remain actively implanted worldwide, includingan estimated 199,642 in the U.S., according to FDA.

When FDA approved St. Jude's design change, it appeared that the firm did not need to initiate a recall, FDA spokeswoman Deborah Kotz said in an email.

"Available data available regarding the rate of overall adverse events indicated the risk to patients was low and was considered consistent with overall rates observed with other makes and models of implantable defibrillators," Kotz said. "Manufacturers are not required to initiate a device recall for changes to medical devices that are not in violation of the Federal, Food, Drug and Cosmetic Act (FD&C Act)."

Discover more about connected medical device innovation at BIOMEDevice San Jose, December 7-8, 2016.

Lithium batteries provide charges to the devices' capacitors, which deliver the high-voltage shocks that bring a patient's heart to normal rhythms. The chemical reaction that occurs results in the formation of lithium particles that can deposit in a location that causes a short circuit,that could lead to premature battery depletion over the course of a day to a few weeks, the company explained.

The design change was made to the insulation inside the battery, adding an internal barrier to address the risk that a lithium deposit could cause a short, it added.

St. Jude executives told the Star Tribune that they worked to address the battery issue as quickly as possible with the information they had. The company began working on the issue after it was first revealed in a December 2014 journal article, according to the newspaper.

St. Jude also acknowledged that it continued to ship old devices for 17 months after changing the design to lower the risk of rapid battery depletion, the report says.

"We have a device that at that time is performing well, and we are making it even better," St. Jude chief medical officer Mark Carlson, MD, told the newspaper in describing the company's reasoning behind its May 2015 decision not to alert the public to the design change. "If we had known, or the [St. Jude] Medical Advisory Board had known in 2015 what we know in 2016, I'm sure that their advice and our actions would have been very different."

Devices affected by the recall include St. Jude's Fortify VR, Fortify ST VR, Fortify Assura VR, Fortify Assura ST VR, Fortify DR, Fortify ST DR, Fortify Assura DR, Fortify Assura ST DR, Unify, Unify Quadra, Unify Assura, Quadra Assura, and Quadra Assura MP.

ICDs and CRT-Ds are both implanted under the skin in the upper chest area with leads that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

Nancy Crotti is a contributor to Qmed.

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[Image of Fortify VR courtesy of St. Jude Medical]

Zimmer Biomet Buys Telerehabilitation Platform

The acquisition of RespondWell adds to the "Signature Solutions" array of technologies and services that the orthopedics giants is packaging together for healthcare providers.

Chris Newmarker

RespondWellZimmer Biomet recently announced that it is acquiring RespondWell, a telerehabilitation technology meant to provide personalized, clinician-supervised post-surgical physical therapy to people in their own homes.

RespondWell's offerings include its [email protected] online program that takes users through healthcare provider-chosen physical therapy routines. It's also offered its [email protected] online wellness exercise program.

Financial terms of the transaction were not disclosed. RespondWell will be added to the Signature Solutions package of technologies and services that Zimmer Biomet has started to offer to improve recoveries from orthopedic procedures. Such services could increasingly be in demand because both public and private healthcare payers, in the U.S. and beyond, are increasingly bundling payments for such procedures in order to steer healthcare providers toward focusing on the value of care versus its quantity.

"The new value-based reimbursement environment compels hospitals and providers to assume responsibility for patient outcomes well after discharge and through the critical rehabilitation period," David Nolan, group president of biologics, extremities, sports medicine, surgical, trauma, foot and ankle and office based technologies, said in a news release.

"Integrating an innovative and comprehensive telerehabilitation program into our Zimmer Biomet Signature Solutions offering addresses the emerging need for healthcare providers to oversee and optimize post-surgical recovery outcomes in order to maximize value across the entire episode of care," Nolan said.

Discussions Zimmer Biomet has had with large academic institutions have included the possibility of deep partnership that include risk sharing, CEO David Dvorak explained during an earnings call with analysts on Monday.

"To do that well, obviously, it requires an end-to-end management in the episode of care. And that's where the patient engagement tools become so important," Dvorak said during the call, which was transcribed by Seeking Alpha.

Zimmer Biomet's stock was down about 13% in Monday afternoon trading, to about $16 per share, after the company reported third quarter sales of $1.83 billion, up 4% year-over-year but below expectations. Dvorak cited problems transitioning supply-chain infrastructure; Zimmer and Biomet closed their $14 billion merger in June 2015.

"In response to this challenge, we have accelerated work to enhance certain aspects of our supply-chain infrastructure as we harmonize and optimize our sourcing, manufacturing and quality management systems," Dvorak said.

Discover how reimbursement trends are affecting connected medical devices at BIOMEDevice San Jose, December 7-8, 2016.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image courtesy of RespondWell]

FDA's Essure Black Box Warning Criticized

Some patient advocates say it doesn't go far enough when it comes to warning about Bayer's controversial birth control device. 

Chris Newmarker

Updated November 1, 2016


FDA on Monday issued its final guidance for a black box warning for Bayer's controversial Essure sterilization device.

Some activists--already critical at what they said was foot-dragging by the agency--now complain that the warning doesn't reflect the actual dangers associated with Essure.

About 750,000 women have had Essure implanted since FDA approved it in 2002, according to The Associated Press. But reports of serious complications have increasingly dogged the device, which is meant to be a less-invasive alternative to tubal ligation. As of early this year, FDA had received nearly 6000 reports of problems related to Essure.

FDA acknowledges in its new guidance that its official believe some women are not receiving or understanding information regarding the risks and benefits of permanent tubal implants for sterilization.

Here's the example FDA provides of an Essure black box warning:

"WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device."

Rep. Mike Fitzpatrick, R-PA, a major medical device safety advocate in Congress, said the warning doesn't go far enough, and highlights why a law needs to be passed to revoke Essure's approval. "A boxed warning and patient checklist highlight the severe risks of Essure--but they're not legally enforceable requirements. Tens of thousands of women have been harmed by this unsafe medical device, including hundreds of fetal deaths," Fitzpatrick said. 

Holly Kelly Ennis of Ennis & Ennis P.A. (Miami, FL), one of the law firms involved in Essure litigation, complains that the warning "fails to address many of the serious and significant injuries caused by the device."

"While thousands of women affected by the device feel a BBW is mandated, the proposed warning falls woefully short; failing to address many of the other severe and significant injuries, including: chronic inflammation and foreign body reaction, chronic joint and back pain, chronic headaches, increased risk of autoimmune issues (including Lupus, MS, thyroid issues and Fibromyalgia), severe bloating/distended abdomen, hair loss, increased risk of ovarian, uterine and fallopian cysts and brain fog/cloudiness/confusion," Ennis writes in a blog post.

The FDA guidance also includes an example of a patient decision checklist. The checklist, for example, mentions that Essure includes nickel, titanium, iron, chromium, and tin, as well as a material called polyethylene terephthalate (PET)--and that rash and itching may occur even among people who have not had allergic sensitivities to such materials in the past. 

Discover more about connected medical device innovation at BIOMEDevice San Jose, December 7-8, 2016.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Essure image courtesy of Bayer]

PFO Occlusion Device Approved in United States

PFO Occlusion Device Approved in United States

The Amplatzer PFO Occluder from St. Jude Medical has been approved by FDA to close patent foramen ovale in ischemic stroke patients.

St. Jude Medical's Amplatzer PFO Occluder for patent foramen ovale (PFO) has received FDA approval, the company announced on October 28. The device, made of two nitinol mesh disks with thin polyester fabric, can now be used in the United States to close the PFO--a congenital hole in the tissue between the heart's left and right atria--in patients who have suffered an ischemic stroke, in order to reduce risk of recurrent stroke.

Although PFO is relatively common, observed in about a quarter of adults, in some cases it is thought to allow paradoxical thromboembolization, enabling a clot to travel to the brain and result in an ischemic stroke, according to an FDA executive summary prepared for the advisory panel on the Amplatzer device. Ischemic stroke patients who also have a PFO are often prescribed antiplatelet or anticoagulant drugs. 

Learn about "Designing Smart Medical Devices with Force-Sensing Technology" at BIOMEDevice San Jose, December 7-8.

FDA's approval makes the Amplatzer PFO Occluder the only approved device in the United State for PFO closure, though other devices have been used off-label for PFO closure. 

The Amplatzer PFO Occluder was studied in the Randomized Evaluation of recurrent Stroke comparing PFO closure to Established Current standard of care Treatment (RESPECT) trial. PFO closure with the device, which is delivered percutaneously using a catheter, showed a benefit and cut the risk of recurrent stroke by more than half versus medical management, according to a St. Jude Medical press release.  

"This is a well-studied therapy with a strong safety profile," Jeffrey Saver, MD, director of the stroke center at UCLA and professor of neurology at David Geffen School of Medicine, said in the release. "Given what we know about the devastating effects of ischemic stroke, the AMPLATZER PFO Occluder is a compelling treatment option in preventing another stroke for patients with a history of cryptogenic stroke and a PFO who are otherwise young and healthy."

The Circulatory System Device Panel, an FDA advisory committee, considered the device in May 2016 and voted 11-5 that the benefits of the Amplatzer PFO Occluder outweigh the risks. While the panelists voted 15-1 that there was reasonable assurance of the device's safety, the 9-7 vote on its efficacy for the intended use was closer.

"The Amplatzer PFO Occluder procedure takes less than one hour to complete, can be performed with conscious sedation and subsequently provides these patients with over a 50% reduction of risk for having another stroke for many years to come," John Carroll, MD, director of interventional cardiology and the Cardiac and Vascular Center at the University of Colorado Hospital, said in the company release. 

Well Fargo senior analyst Larry Biegelsen wrote in an October 28 research note that he expects the FDA approval to contribute "modest incremental revenue" to the company.

[Image courtesy of ST. JUDE MEDICAL]

4 Ways Virtual Reality Is Being Used in Healthcare

Virtual reality already has a number of important uses, and is definitely a value-add that medical device designers should not ignore.

Qmed Staff

Virtual reality has become a legitimate technological platform for improving healthcare, Daniel Kraft, MD, chairman of the Exponential Medicine Conference, recently explained to Worrell Design

Here are the four major ways Kraft sees virtual reality being used in medicine:

  1. Pain management. Just over the summer, AppliedVR (marketing image on right) announced a partnership with Cedars-Sinai Medical Center to bring virtual reality content to patients in the hospital's orthopedic, spine, and surgery center. The whole idea is to help patients manage pain by distracting them with an interactive world full of games. 
  2. Medical Education. In April, Medical Realities (London) announced it was the first in the world to present a virtual reality 360-degree live stream of a surgery on a cancer patient to anyone who had a VR headset. The company is among a number using 360 video and 3-D interactive content to bring both physicians and students inside virtual operating environments to experience procedures they may not have ready access to otherwise.
  3. Mental Ilness Treatment. Bravemind, for example, is a virtual reality-based therapy tool for post traumatic stress disorder (PTSD), a major concern for the U.S. military after the highly stressful combat situations of the Iraq and Afghanistan wars. Bravemind helps PTSD sufferers gradually relive their previous traumatic experiences in a controlled environment in order to better process through the emotions resulting from the experience. 
  4. Physical Therapy and Excercise. Startups including VirZoom and Widerun are combining cardio workouts with virtual reality.

Check out more examples in Worrell's blog post. This Qmed slideshow from April has even more examples. 

Find out more about connected medical device innovation at BIOMEDevice San Jose, December 7-8, 2016. 

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image courtesy of AppliedVR]

Who Is the Most Innovative Exhibitor at BIOMEDevice San Jose?

Compete for the BIOMEDevice San Jose Innovation Prize, which acknowledges the most innovative new products, services, and technologies developed by BIOMEDevice San Jose exhibitors. The deadline is November 11. Read on to find out how to enter. 

Qmed Staff

Invention Innovation Light Bulb MedtechUBM is looking to identify the most innovative exhibitors at BIOMEDevice San Jose and give them the recognition they deserve. The BIOMEDevice San Jose Innovation Prize is a contest acknowledging the most innovative products, services, and technologies developed in recent years by exhibitors at the conference and expo, held December 7-8, 2016, in San Jose.

Finalists in the contest will be honored at the show as well as on UBM's industry-leading Qmed. Finalists will also be included in an Innovation Prize tour at BIOMEDevice San Jose that will attract attendees to check out their technologies at the event.

The winner will be announced during the show and will be promoted in editorial coverage as well.

To enter, please complete the form below by 5 p.m. Pacific time on Friday, November 11, 2016.

Winning the BIOMEDevice San Jose Innovation Prize pays benefits going forward: The company named the most innovative in the contest will receive a 22-inch-by-28-inch sign to display at BIOMEDevice San Jose and future shows.

This is a chance to showcase the best your company has to offer in the design and manufacturing of medical devices, and get public recognition for it.

Here are the steps in the contest:

  • The editorial team will ask our online audience to help select five finalists among the submissions, which will be highlighted during an Innovation Prize Tour at BIOMEDevice San Jose.
  • During the tour, a group of attendees will stop by the booth at a designated time to learn more about your firm's technology. After the tour is completed, the attendees will cast votes for the technology they think is the most innovative. In the event of a tie, our editorial team will help select a winner.

Eligibility and Requirements for Participation

The official rules are explained in detail on this page, although here is a summary. Interested companies must:

  • Be a 2016 BIOMEDevice San Jose exhibitor.
  • Have company operations in the United States or Canada.
  • Showcase an innovation developed between 2014 and the present relevant to the medical device industry.
  • Answer the required questions in the form below in no more than 100 words each. Make sure to adequately state your case as to why your product, service, or technology is truly innovative, and to include an image (ideally less than 1 MB in size) and, if available, a video showing how the product works. (Note that the media you submit could be used in a future news story.)
  • Be willing to have their technology featured in a Innovation Tour at BIOMEDevice San Jose, where a group of attendees stops by the booth to learn more about the relevant technology.

To enter, please complete the form below by 5 p.m. Pacific time on Friday, November 11, 2016.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image from Pixabay]