The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines. The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K. The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) — are in the […]
Materials Testing
FDA says Philips knew about toxic foam for years before massive recall
The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices. The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware […]
FDA requests safety testing of replacement foam in Philips sleep devices recall
The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them. The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based […]
Everything you need to know about medical device creation
Medtech development is hard. Medical device creation can require manufacturing know-how in areas as wide-ranging as electrical components, high-performance polymers, molding and machining — and that doesn’t even include the required expertise in design, regulatory requirements and achieving reimbursement. The good news is that there is now a whole ecosystem of specialized experts serving the […]
Sotera Health buys BioScience Laboratories to boost Nelson Labs business
Sotera Health (NASDAQ:SHC) recently announced that it has acquired Bozeman, Mont.–based BioScience Laboratories in a deal that will expand the U.S.-based antimicrobial and antiviral testing capabilities of Sotera Health’s Nelson Labs business. The financial terms of the deal were not disclosed in the March 10 announcement. BioScience Laboratories provides topical antimicrobial product testing in the […]
MIT researchers tout origami-inspired medical patch for internal injuries
Engineers at MIT are touting a medical patch capable of being delivered through narrow spaces to patch up internal injuries. With inspiration from the art of origami, the engineers designed the patch to be folded around minimally invasive surgical tools and delivered through airways, intestines and other narrow spaces to patch up internal injuries, according […]
DTW Podcast: Hear the future of AI, 3D, and Dx from Edwards, Stryker, Evercore, Checkable
In this week’s episode of DeviceTalks Weekly we review the Medical Design & Outsourcing’s Women in Medtech issue — bringing you insights through interviews with Katie Syzman, corporate VP and the GM of critical care at Edwards Lifesciences, Naomi Murray, Stryker’s director of advanced operations, and Patty Post, CEO of Startup Checkable Medical. Szyman […]
How a top research lab pivoted to fight COVID-19
A top medtech research site, the Boston-based Karp Lab has responded to COVID-19 with a virus-fighting nasal spray, better mask straps and much more. COVID-19 completely disrupted the work at Jeff Karp’s medical engineering lab at Brigham and Women’s Hospital in Boston. That’s not necessarily a bad thing. One company that was planning to do […]
MD&M West exhibitors you need to know
MD&M West — set for Feb. 11-13, 2020 — is billed as the largest medical device manufacturing event in the world. Now in its 35th year, it showcases hundreds of industry suppliers and attracts thousands of medical device industry insiders. Strolling around the show floor at the Anaheim Convention Center, in Anaheim, Calif., visitors will see […]
Have government scientists solved the artificial hips corrosion problem?
Argonne National Laboratory researchers tested metal alloys that ortho device companies have used in artificial hips for decades. Materials scientists at the U.S. Department of Energy’s Argonne National Laboratory usually test metal alloys for their ability to contain nuclear waste for millions of years. A couple of years ago, two of them decided […]
ECRI Institute to open international medtech testing lab in Malaysia
ECRI Institute said it is launching its first medical device evaluation laboratory outside the United States. The ECRI International Research Centre in Selangor, Malaysia will evaluate medical devices used across all care settings in Europe and Asia to help medical professionals make informed decisions that improve patient safety, according to the nonprofit, independent organization. It is […]
