• Reusable Devices: How Effective Is Your Cleaning Validation?

    If you're developing a medical device that will be reprocessed, you've got a lot to consider.Daphne AllenAlpa Patel, B.S. RM (NRCM)Developing a cleaning validation for a reusable medical device presents several challenges. How are you addressing them?“There have been many issues over the last 7 years, so there’s increased scrutiny of cleaning validations,” explained Alpa Patel, B.S. RM (NRCM) of Nelson Laboratories. “FDA published the 2015 guidance, ‘Reprocessing Medical Devices in Health Care...
  • Is AngioDynamics Right to Pick a Fight With Bard?

    AngioDynamics is suing Bard for allegedly violating federal antitrust laws by tying the sale of its tip confirmation system to its own line of PICCs.Amanda Pedersen AngioDynamics is none too pleased with competitor C.R. Bard’s sales practice in the peripherally inserted central catheters (PICC) market.The Albany, NY-based company is suing Bard for allegedly violating federal antitrust laws by tying the sale of its tip confirmation system to its own line of PICCs. This puts AngioDynamics at...
  • Can the Newest Da Vinci Robot Smash Cost Barriers?

    The newest addition to Intuitive Surgical’s da Vinci family provides a lower-priced surgical robot with the option to upgrade to more advanced features as needed.Amanda PedersenThe new da Vinci X could address a major adoption barrier in robotic surgery by offering a lower-cost system that customers can upgrade as their needs grow. Intuitive Surgical added a new robot to its da Vinci family, reinforcing the company’s dominance in a space that is expected to see some competitive disruption...
  • How A Wearable is Making Diabetes Management More Efficient

    The wearable, known as the V-Go, aims to make insulin delivery for patients with Type 2 diabetes simpler and more efficient.Kristopher Sturgis New data suggests this insulin patch, known as the V-Go, has cost benefits as well as ease-of-use perks for diabetes patients People with Type 2 diabetes may have an innovative new treatment option that could not only make managing their disease easier, but also much cheaper. Valeritas reported the results of two new studies that...
  • Meeting a Shifting Demand for Sterilization

    A supplier of both turnkey sterilization systems and contract sterilization services shares its perspective.Daphne AllenCosmed recently built a 13-pallet, truck height (110”) sterilizer.After acquiring a contract ethylene oxide (EO) sterilization facility in Erie, PA, Cosmed Group Inc. is returning to the medical device industry.Cosmed purchased the facility from iuvo BioScience in December 2016. Clark W. Houghtling, VP, business development and technical affairs for Cosmed, told Qmed that...
  • Senseonics’ $41M Raise Fuels Confidence in Eversense CGM

    Roche's participation in the stock sale is seen as a good sign, with proceeds expected to carry the company through the FDA process by the end of the year.Amanda Pedersen Roche and other key investors are showing continued confidence in a Germantown, MD-based company that is trying to bring its implantable continuous glucose monitoring (CGM) system to the U.S. diabetes market. Senseonics said it raised about $41 million in a stock sale, thanks in large part to its international...
  • Ex-Stryker Rep Loses in Court, Again

    Christopher Ridgeway had appealed a 2016 jury verdict in which he was ordered to pay nearly $750,000 for breach of contract, breach of fiduciary duty, and a trade-secrets claim.Amanda Pedersen A former Stryker employee who had accused the company of fabricating the non-compete document that was used against him in court last year, resulting in a loss of nearly $750,000, failed to prove in an appeal that any such fraud occurred.Don't miss the MD&M East Conference and Expo, June 13-15,...
  • Abbott Recalls Thousands of LVAD Controllers After 26 Deaths

    Heart failure patients who died had tried to switch the controllers on their own, FDA says.Nancy Crotti Abbott has received 70 reports of incidents in which the HeartMate II's pocket system controller malfunctioned after an exchange. The company provides the backup controller to the patient in case of emergency. Abbott is recalling nearly 29,000 HeartMate II heart failure device controllers following 26 deaths and 19 injuries among patients who tried to exchange their own controllers...
  • 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...