• FDA on Its Uptick in PMA Approvals

    CDRH head Jeffrey Shuren recently stated that the FDA would like to be the first in the world to clear medical devices, as long as it preserves its standards for ensuring safety and efficacy. With PMA approvals hitting a 15-year high, we reached out to FDA for insights into what is enabling the expedited device reviews and whether the uptick in approvals was correlated by an increase or decrease in adverse events related to PMAs. Qmed StaffFDA spokesperson Deborah Kotz points to an array of...
  • Stryker Accused of Fraud and Off-Label Promotion of Bone Putty

    Stryker is on the receiving end of two new product liability lawsuits related to its bone morphogenetic protein (BMP) OP-1 products, which had been approved by FDA as a “humanitarian device exemption,” absolving the manufacturer from having to prove the effectiveness of the product.Qmed StaffUpdated December 8Recent lawsuits filed in Middlesex County in Massachusetts accuses Stryker of fraud, negligence, and breach of warranty related to its OP-1 putty. The putty is similar the Medtronic’s...
  • 7 Star Wars Lessons for Medtech That Would Make Yoda Proud

    Image from PixabayMuch you can learn from the science fiction saga when it comes to creating great medical devices. “Do. Or do not. There is no try.”Brian Buntz and Chris NewmarkerThe new Star Wars: The Force Awakens should hopefully not “suck,” as director J.J. Abrams recently promised People magazine.Slideshow: Top 10 Star Wars Medical TechnologiesThe movie, which hits U.S. movie theaters on December 18, might even inspire, and provide some useful lessons for medical device designers and...
  • The Amazing Water Adhesive Developed at MIT

    The synthetic, sticky, biocompatible hydrogel is mostly water, and can help suspend a 55-lb weight.Qmed StaffEngineered hydrogel being pulled away from a glass surface. (Image courtesy of Felice Frankel and MIT)MIT researchers recently announced strides when it comes to synthetically recreating the natural hydrogels that allow mussels and barnacles to tightly glue themselves to ship hulls, or for our own tendons and cartilage to stick to bones. The synthetic, sticky hydrogel developed...
  • An Implantable LED to Take Your Pain Away

    A new flexible, biocompatible optogenetic device could help researchers better understand the neurological basis of pain, and potentially help provide relief for patients suffering from chronic pain.A wireless LED to implant in mice (Image courtesy of Nature Biotechnology)Kristopher SturgisChronic pain remains as difficult to understand as it is to treat for both doctors and patients who work to understand the source and cause of pain in the body. Recently, researchers from Washington...
  • PMA Approvals Hit 15-Year High

    FDA’s PMA approval rate was 98% in the most recent fiscal year. The agency hopes to further improve device approval timelines while simultaneously safeguarding patients. Brian Buntz and Chris NewmarkerPMA approvals are now substantially quicker than they were in 2008 and 2009. Image drawn from an FDA report. The FDA has approved 98% of PMA applications during its most recent fiscal year ended September 30, marking the highest approval rate in at least 15 years and the first time the approval...
  • Is Medtech's Next Big Thing Years Away?

    It could take years before transcatheter mitral valve replacement truly hits the market, an analyst in the space is warning.Nancy CrottiThis screen grab from an animation shows the Tendyne Bioprosthetic Mitral Valve deploying. Abbott announced in July it would acquire the technology for $225 million. (Image courtesy of Tendyne Holdings)Device makers are sinking hundreds of millions of dollars into technology to fix leaky mitral valves, although they’re years away from bringing the...
  • Why Healthcare Needs to Be Destroyed to Be Saved

    A medical futurist called for seismic shifts in healthcare to make it more efficient, transparent, and customer friendly, arguing that technologists should play a leading role in driving that change.Brian BuntzSo you want a healthcare revolution? That was essentially a question posed by a recent keynote from Joe Flower, a healthcare futurist and author, who essentially recommended a ‘blow up, rebuild’ approach for healthcare on Thursday at BIOMEDevice San Jose.“We could do healthcare for...
  • There's Still Hope for Medical Device Startups

    Much of the venture funding for medical devices has dried up. But that’s not necessarily a bad thing, said members at a panel at BIOMEDevice San Jose. Brian BuntzOpportunities abound in the medical device space.That was the impression one got from listening to a Tuesday panel of Silicon Valley–based medical device entrepreneurs. One panelist, Kathy Stecco, MD, said Wednesday that she founded a startup that had a 20x return—without any venture capital backing.“I am pushing people away from...
  • Google Files Patent for Surgical Laser Technology

    A recently published Google patent describes a laser ablation device with an active tracking system that allows the laser to work even when a patient is moving.Nancy CrottiAn illustration from Google's patent application for the laser ablation deviceGoogle's foray into medical technology appears to be continuing. The company, which now has a sister Google Life Sciences business operating under its Alphabet parent company, has applied for a patent for a laser ablation surgical device.Slideshow:8...
  • The Medtech Industry Can't Hide from Security Flaws

    The medical device industry should more thoroughly consider the security ramifications of wireless technology in next-gen medical devices, according to a prominent security researcher.Brian BuntzJay RadcliffeAre medical device designers so enamored with technology that they are failing to take cybersecurity seriously?That was the question posed by Jay Radcliffe, a senior security consultant at Rapid7, during a Wednesday talk at BIOMEDevice San Jose.Technology, for example,...
  • Public Safety Warnings from FDA Spike in 2015

    FDA has had a been a busy year releasing Medical Device Safety Communications safety communications. Outlined in the warnings include problems related to duodenoscopes, reprocessed flexible bronchoscopes, and cybersecurity. Qmed DailyTo date, FDA has released 18 safety communications in 2015. Compare that with 2014, when it released six such communications, or 2013, when it released nine. Several of the documents were related to themes such as the ability of infusion pumps to be hacked,...
  • Human Gene Editing Tech Sparks Debate

    Synthetic biologists continue to advance a molecular editing system known as CRISPR that provides the opportunity to edit the DNA of living cells with unprecedented precision. While the technology’s ability to safely alter human DNA has yet to be proven, MIT scientists claim that they’ve all but removed potential errors from the technology. Kristopher SturgisDiagram of the CRISPR prokaryotic viral defense mechanism from WikipediaIn April 2015, Chinese scientists announced that they were the...
  • Startup’s Plan to Use AI to Resurrect the Dead Raises Eyebrows

    A startup states that it can give humans the option of immortality within 30 years. While it has received international media attention, details of its plans remain scarce. Qmed StaffHumai states on its website that it is working towards "Human Resurrection through Artificial Intelligence."The startup Humai (Los Angeles) says it is working on using artificial intelligence and cryonics to give people the option of living eternally. While it is too early to tell if it is a hoax or a serious plan...
  • Medtronic Recalls Nearly 100,000 Pacemakers

    The medical device company reports that a battery problem in one of its pacemakers could interfere with normal device function.Qmed StaffA recent recall involving roughly 96,800 InSync III pacemakers has been given Class 2 status by the FDA. The recall, which covers three different models of the pacemakers, relates to a potential battery defect. In a letter addressed to doctors, Medtronic notes that 30 devices so far have been demonstrated to have a problem with unexpected high...
  • Top 10 Biomedical Engineering Schools by Salary

    Engineering is one of the most handsomely rewarded academic disciplines and, engineering continues to be the highest-paying major at the baccalaureate level. Biomedical engineers’ compensation is competitive with the pay offered by many other engineering niches.Qmed StaffUpdated December 22, 2015According to the U.S. Bureau of Labor Statistics, biomedical engineers take home an average salary of $91,760—more than the roughly $87,000 salary range that is the average for civil and mechanical...
  • Does Disruptive Innovation Really Have to Be So Disruptive?

    The rate that technological breakthroughs are being developed continues to increase at breakneck speed, leading to seismic shifts in how people interact with technology on a daily basis. It is thus vital to ensure that developers of new technologies consider human behavior to engage users amidst a landscape marked by unprecedented change. Craig SchererCraig Scherer is a senior partner and cofounder of Insight Product Development.  The digital health and Internet of Things...
  • The Guide to the Future of Medicine: Infographic

    Learn more about user-centered design in a workshop dedicated to the topic at BIOMEDevice San Jose, December 2–3.
  • Is This a Cheaper Way to Do Medical Imaging?

    MIT researchers used sophisticated mathematical equations to turn an off-the-shelf depth sensor, such as a Microsoft Kinect, into an biomedical imaging tool.Nancy CrottiThese images depicts the phase information contained in six of the 50 light frequencies the MIT biomedical imaging system analyzes. (Image courtesy of MIT)A team of Massachusetts Institute of Technology researchers has come up with a way to do medical imaging for much less money than current technology costs.The researchers...
  • FDA Warns About Deadly Device Coatings Problems

    Coating adhesion problems related to guidewires and other devices apparently aren’t going away, if a Monday safety communication out of FDA is any indication.Chris NewmarkerSome failing wires experience PTFE delamination. (Image courtesy of Surface Solutions Group)FDA is warning health providers of serious adverse events related both the hydrophilic and hydrophobic coatings used on guidewires and a host of other intravascular procedure devices.The medical device industry has already been aware...