• Robert Fischell: When I see a Problem, My Mind Sees Solutions

    The 2017 MDEA Lifetime Achievement Award winner shares a few of his best stories, including how he put Alfred Mann in the medical device business.Amanda PedersenIf you get to be 88 years old, you’ll find you have a lot of good stories to tell. Robert E. Fischell, PhD, is certainly no exception to that rule.Robert E. Fischell, PhD, will receive the MDEA Lifetime Achievement Award during a special ceremony at MD&M East in New York City on June 13, 2017.Fischell, a prolific inventor and a...
  • New Expectations for Biocompatibility Testing: Are You Ready?

    Are you aware of the regulatory changes and testing advances involving biocompatibility?Daphne AllenImage of an in vitro irritation test courtesy Nelson Laboratories. Biocompatibility testing requirements for medical devices are changing. “A lot of things are happening, on all fronts,” Thor Rollins, biocompatibility specialist at Nelson Laboratories LLC, told Qmed. “ISO 10993 changed, FDA released a new guidance document for ISO 10993, and Europe issued new medical device regulations....
  • Behind the Design: Sympfiny Multiparticulate Delivery System

    HS Design's Michael Quinn explains how his team used a familiar form factor and other design elements to make it easier to get kids to take their medicine.Jamie HartfordHS Design won a $50,000 grant from Pfizer and the Institute of Pediatric Innovation for its Sympfiny design.As any parent knows, getting kids to take their medicine can be a struggle. In fact, the average compliance rate in children is only around 58%, according to one study. The problem—as any kindergartener will...
  • Abbott Issues a Massive Catheter Recall

    One patient has died and 19 were injured by coronary dilation catheters, FDA said.Nancy Crotti p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 14.0px 'Helvetica Neue'; color: #323333; -webkit-text-stroke: #323333} span.s1 {font-kerning: none} Abbott's NC Trek RX Coronary Dilatation Catheter is among the devices impacted by the company's recall. Abbott is recalling 132,040 coronary dilation catheters for issues with inflating or deflating the balloon within the protective sheath.The recalled...
  • Is the Latest FDA Setback Rock Bottom for Endologix?

    Endologix now needs to conduct a confirmatory clinical trial for its Nellix endovascular aneurysm sealing system, pushing the projected FDA approval to at least 2020. Endologix’s Nellix EndoVascular Aneurysm Sealing (EVAS) system was one of the most hotly anticipated medical devices of 2016, with management anticipating FDA approval by the end of that year, according to an MD+DI roundup. But fast-forward to May 2017, and the wait isn’t over yet—and won’t be anytime soon.Although Endologix...
  • CE Mark Suspension Adds Insult to GI Dynamics' Injury

    The company has a new management team in place, including a chief compliance officer, to fix quality control problems related to the EndoBarrier device.Amanda PedersenGI Dynamics has faced multiple regulatory setbacks with its EndoBarrier device, which is intended to treat obese patients with Type 2 diabetes. GI Dynamics Inc. is facing yet another hurdle with its EndoBarrier system, only this time the roadblock is on the other side of the pond. The company's CE mark for the EndoBarrier...
  • PFO Closure Device May Drastically Reduce Risk of Recurrent Stroke

    A study of Gore's Cardioform septal occluder also shows it reduced new brain infarct, including silent stroke, by nearly 50%.Nancy Crotti  A new study shows that a device to plug a hole in the heart can reduce the risk of recurrent stroke by more than 76% when combined with antiplatelet therapy than such therapy can do alone.W. L. Gore & Associates, manufacturer of the Cardioform septal occluder, is hoping the study’s results will persuade the American Academy of Neurology to...
  • FDA Warns of Faulty Blood-Based Lead Test Results

    CDC recommends retesting of certain children, pregnant women, and nursing mothers who have been tested for lead exposure with Magellan Diagnostics’ lead tests.Qmed Staff FDA is investigating a problem related to Magellan Diagnostics’ lead tests after data indicated that the tests may provide inaccurately low results when performed on blood drawn from a vein. The agency said laboratories healthcare professionals should not use any Magellan lead tests with blood drawn from a vein.The agency...
  • New CMS and FDA Heads Urged to Back Effort to Add UDI to Claims Forms

    A years-long initiative to add unique device identifiers to insurance claims forms continues, with supporters asking the new directors of CMS and FDA to rally behind the cause.Marie ThibaultA group of healthcare systems, payers, medical societies, and medical product companies have asked the new leaders of CMS and FDA to support a push to add unique device identifiers (UDIs) to insurance claims forms.In a letter addressed to CMS Administrator Seema Verma, MPH and FDA Commissioner Scott Gottlieb...
  • Can Boston Scientific Still Find Fertile Ground for Lotus?

    Boston Scientific Lotus valve demonstrated superior efficacy in a head-to-head study against Medtronic’s CoreValve, but more Lotus patients needed a permanent pacemaker compared to the CoreValve patients.Amanda PedersenNeedham & Company's Mike Matson said he sees potential for Boston Scientific’s TAVR sales to eventually exceed $1 billion. The global TAVR market is expected to reach $4 billion by 2020. It hasn’t been easy for Boston Scientific to find its place in the fertile soil...
  • Why is Citron Dumping on the 'Poop in a Box' Test?

    Shares of Exact Sciences got flushed down the toilet after a short seller dumped on its colon cancer test, but at least one analyst defended the diagnostic company.Amanda Pedersen Exact Sciences' stock plunged almost 4% after short-seller Citron Research attacked Cologuard, a stool-based DNA test for colorectal cancer. Short-seller Citron Research has placed Exact Sciences in its crosshairs with a report that dumps on the diagnostic company’s “seriously inferior” colon cancer test,...
  • How Magnetic Pulses Are Lifting Moods

    FDA cleared a new transcranial magnetic stimulation device for adults with major depressive disorders.Kristopher SturgisFDA cleared the MagVita TMS system with MagPro R20, developed by MagVenture Inc., for adults with major depressive disorders who have not responded to traditional antidepressant drugs. Transcranial magnetic stimulation (TMS) has been gaining traction in recent years among clinicians, patients, and even insurance companies as a method of treating depression in adults who...
  • Can Magnets Help Infants With Esophageal Defect 'Flourish'?

    Cook Medical’s Flourish device uses magnets to pull the upper and lower esophagus together, allowing food to reach the stomach.Nancy Crotti Cook Medical's Flourish pediatric esophageal atresia device is used to non-surgically repair the esophagus in infants who were born with their upper esophagus disconnected from their lower esophagus and stomach. FDA has given a non-surgical device to help infants feed normally a humanitarian use approval.Cook Medical’s Flourish pediatric...
  • Meet the Bot That Could Slither Through Your Gut

    Medrobotics receives FDA clearance to market its steerable robotic surgical platform for colorectal surgeries in the U.S. Kristopher SturgisFDA cleared Medrobotics' Flex Robotic System for colorectal procedures. Medrobotics Corp. is taking its Flex Robotic System to places no other steerable robotic surgical platform has gone before: the human gastrointestinal system. The company received FDA clearance to market its Flex Robotic System for colorectal procedures, making it the first such...
  • Consider Triclosan-Coated Sutures for Preventing SSI, Advises CDC

    CDC joins the World Health Organization in considering the impact of triclosan-coated sutures on reducing SSI risks. Daphne AllenThe Centers for Disease Control and Prevention (CDC) has revised its guidelines for preventing surgical site infections. Among its recommendations to health professionals is to “consider the use of triclosan-coated sutures for the prevention of SSI,” according to “Guideline for the Prevention of Surgical Site Infection, 2017,” published in the May 3 edition of...
  • Bos Sci's S-ICD Passes Muster in the Real World

    S-ICD system demonstrates high effectiveness, and low complication rate in largest prospective study of real-world patients.Amanda PedersenThe Emblem MRI S-ICD, Boston Scientific's latest-generation S-ICD system, is being evaluated in the company's recently-initiated MADIT S-ICD study. It’s one thing when a device performs well during a carefully-controlled clinical trial with a select group of patients, but what happens after it makes it into the actual clinical setting? Both FDA and...
  • How Abbott is Putting St. Jude Tech to Work

    The company integrated St. Jude’s EnSite Precision cardiac mapping system into its new contact force ablation catheter for atrial fibrillation.Nancy CrottiAbbott's latest innovation to treat atrial fibrillation, the TactiCath contact force ablation catheter, is integrated with St. Jude's EnSite Precision cardiac mapping system. Abbott is wasting no time in employing technology acquired as part of its $25 billion purchase of St. Jude Medical.Learn from product design experts at the MD&M...
  • How Medtronic is Setting the Pace in Heart Failure

    FDA approved a new portfolio of MR-conditional pacemakers Amanda Pedersen It seems like not that long ago Medtronic was building the world’s smallest pacemaker, the Micra, which represented a major leap in pacemaker technology.But Medtronic is not the type of company to rest on its laurels. The company continues to make noteworthy strides in the heart failure business, most recently with FDA approval of a new platform of MR-conditional quadripolar cardiac resynchronization therapy...
  • Ex-CEO Guilty in Stealing Trade Secrets

    Christopher Barry admitted to pinching proprietary information from one company and taking it to another.Nancy Crotti A former medtech executive has pleaded guilty to stealing trade secrets and giving them to his new employer.Christopher Barry, 46, of Medina, Minn., entered the guilty plea in U.S. District Court in St. Paul. According to the plea agreement, Barry was vice president of research at Lutonix, Inc., a New Hope, Minn. subsidiary of C.R. Bard and maker of the Lutonix 035 DCB, a...
  • Taking the 'Inoperable' Out of Inoperable Brain Tumors

    New data from an ongoing study offers preliminary evidence that Monteris Medical’s NeuroBlate System may be a viable solution for brain tumors that were previously considered inoperable.Amanda PedersenNew data from an ongoing study offers preliminary evidence that Monteris Medical’s NeuroBlate System may be a viable solution for brain tumors that were previously considered inoperable. The words “brain” and “tumor” are all too often accompanied by the word “inoperable,” but a growing body...