Device Safety

Latest Headlines

Latest Headlines

NIH to weigh in on artificial pancreas development at upcoming meeting

Artificial pancreases are moving closer to market and the government wants to weigh in. The National Institutes of Health (NIH) is holding a workshop to discuss the technology and how to make the devices safe and efficient for patients.

California lawmaker calls on FDA to step up oversight amid duodenoscope fallout

Superbug outbreaks tied to duodenoscope devices have caused regulators to step up their oversight of the products. But one lawmaker wants the agency to go even further and is asking Congress to back his efforts.

Harvard team uses bacterial enzyme coating to extend life of implantable devices

The body's response to foreign material--forming blood clots and becoming inflamed--can prevent blood-contacting implants like stents and heart valves from working properly. While the only recourse is to replace the device, Harvard scientists have developed a new biochemical method to coat these devices to preserve their function.

Senator grills Medtronic, FDA over alleged mishandling of Infuse bone graft study data

Medtronic has taken some responsibility for mishandling data from a retrospective chart review of its bone graft, Infuse, after a recent report said that the company allegedly buried side effect reports linked to the product. But Medtronic's response did not appease one lawmaker, who is calling on the company and regulators for more answers.

UPDATED: Medtronic shut down study of Infuse bone graft and tucked away the evidence: Report

Medtronic is coming under fire for shutting down a study of its bone graft, Infuse, and allegedly tucking away the data. A recent report from The Minneapolis Star Tribune said that the company uncovered serious problems linked to the product but didn't immediately tell anyone, which sparked pushback from the government and the public.

Dexcom warns on malfunctioning alarms in latest CGM, German agency discloses

Continuous glucose monitor company Dexcom has hit a stumbling block. Some of its devices, including the G5 receiver for a system that just launched last fall, are not providing the audio alarms and warnings as expected.

FDA nod for tissue containment in power morcellation comes amid ongoing review of cancer concerns

Irish startup Advanced Surgical Concepts has nabbed an FDA nod for its tissue containment system for use with certain laparoscopic power morcellators. The regulatory go-ahead falls under the agency's de novo process that's reserved for low- to moderate-risk devices that are novel.

Duke University sends recs to FDA for new medical device safety evaluation system

Last year, the FDA asked Duke University's Duke-Margolis Center for Health Policy to weigh in on planning for a national medical device evaluation system that could better regulate medical devices. Now, Duke-Margolis has sent its suggestions to the agency about a system that would bring together the government, regulators, devicemakers and patients to improve medical device safety.

Boston Sci suspends EU sales of next-gen Watchman, but CMO says current-gen device is safe and effective

Boston Scientific has suspended European sales of the CE-marked, Watchman FLX to prevent stroke due to a high embolization rate.

Warburg-backed Sterigenics buys Nelson Labs to create largest sterilization, testing firm

Contract sterilization player Sterigenics, which was acquired last year in a deal reportedly valued at $2 billion by private equity firms Warburg Pincus and GTCR, has bought Nelson Laboratories. The deal wraps the largest U.S. sterility testing services for medical devices, pharmaceuticals and tissues into the Warburg portfolio company--making it the largest provider globally of sterilization services and testing, according to the company.