• What Caused Magellan’s Lead Test Problem? FDA is Stumped

    FDA has not been able to identify the root cause of Magellan's inaccurate lead test results, and the recall has been expanded to include two additional testing systems.Amanda PedersenFDA is conducting studies with the CDC to identify the cause of Magellan's faulty blood-based lead tests. Magellan Diagnostics expanded its ongoing recall to include two additional testing systems, the LeadCare and the LeadCare II, because they may underestimate the blood lead levels (BLL) and give inaccurate...
  • 5 Emerging Challenges in Surface Treatment

    Advances in medtech are giving those involved in surface coating a few new issues to consider.Daphne AllenHarland’s FTS 6000 Friction Test System measures both surface friction and coating durability.The bar is being raised for surface treatment in medical device manufacturing. Surfaces have typically been coated or treated to enhance product lubricity and durability, but new trends in medical device manufacturing could present some challenges.For instance, new “multimaterial devices with as...
  • Point-of-Clinic Diagnostics: Shaping the Future for Improved Patient Outcomes

    There is a growing demand for economically viable and flexible diagnostic tools that swiftly deliver accurate results. Dr. Giles SandersTTP’s Desktop Biology service enables diagnostic providers to rapidly convert their biological assays into market-ready point-of-clinic systems capable of producing a result in as little as 15 minutes.Point-of-care diagnostics have been on the cusp of full-scale adoption for the past few decades, but apart from a few cases, this has proven...
  • FDA Clears Debris-Catching Device for TAVR

    Claret Medical said its Sentinel device reduces strokes by 63% in the first 72 hours after TAVR.Amanda PedersenFDA cleared Claret Medical's Sentinel Cerebral Protection System for use during TAVR procedures, following positive input from an FDA advisory panel in March. Transcatheter aortic valve replacement (TAVR) should be safer for U.S. patients, now that FDA has cleared a device designed to catch and remove loose debris before it reaches the brain. Santa Rosa, CA-based Claret Medical...
  • Using Rapid Manufacturing to Mitigate Design Risk in Overmolding and Insert Molding

    Confirming your part design can be molded early in the design process can help reduce risks.Daphne AllenAn insert-molded part with a brass insert. Image courtesy of Proto Labs.Overmolding and insert molding are well established processes for combining two different materials in the same finished part. Such molding techniques are commonly used in medical device manufacturing, but there are still some “unseen risks,” reports Becky Cater, global product manager for injection molding at ...
  • How to Get to the Heart of Stem Cell Delivery

    A new study showed that stem cell delivery using BioCardia’s Helix system resulted in up to 18 times better heart tissue retention of stem cells compared to some standard methods.  BioCardia had its work cut out for it when the company entered the cardiovascular regenerative medicine space. Delivering stem cell therapies into a moving heart – and keeping them there – is inherently difficult. But the San Carlos, CA-based company was up to the challenge, and designed a delivery system...
  • Harmful Chemicals in Spine Implants Prompt Zimmer Recall

    Zimmer Biomet recalled two implantable spinal fusion stimulators after a routine cytotoxicity test indicated high levels of chemicals that could be toxic to tissues or organs.Amanda PedersenZimmer Biomet is recalling its SpF PLUS-Mini and SpF XL llb implantable spinal fusion stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues or organs. The company initiated the recall on April 20 after discovering the problem during routine monitoring,...
  • 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...