Medical Innovation Exchange

Inga Hansen

CDRH Releases New Dataset for Biocompatibility of Medical Devices

CDRH Releases New Dataset for Biocompatibility of Medical Devices     On April 16, the FDA’s Center for Devices and Radiological Health (CDRH) released a new public dataset designed to assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. In a statement from Jeff Shuren, M.D., …

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Flex Recognized as a 2024 World’s Most Ethical Company

Flex Recognized as a 2024 World’s Most Ethical Company     Contract manufacturer Flex has been recognized as one of Ethisphere’s 2024 World’s Most Ethical Companies in the category of industrial manufacturing. The award from Ethisphere requires companies to provide information on more than 240 proof points related to the company’s culture of ethics; environmental, social, …

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FDA Medical Device Sterilization Town Hall Series Continues April 29

FDA Medical Device Sterilization Town Hall Series Continues April 29     As part of its efforts to work with the medical device community on device sterilization alternatives in light of new EPA standards for ethylene oxide (EtO) emissions, the FDA is hosting a virtual town hall on April 29, 2024, from 1:00pm-2:00pm ET. The town …

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Interest Rates, Labor and Cybercrime Keep Pressure on Healthcare

Interest Rates, Labor and Cybercrime Keep Pressure on Healthcare     The various pressures that have been a drag on the healthcare sector—many in place before the disruptions stemming from the COVID-19 pandemic—may relent to some extent this year. But it’s still no time for organizations to let down their guard against the risks. The good …

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Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines     On April 9, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America (“Philips Respironics”), Respironics California, Philips Holding USA, and Roy Jakobs, CEO of Royal Philips, along with …

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FDA to Host Virtual Workshop on ASCA Program Expansion

FDA to Host Virtual Workshop on ASCA Program Expansion     The FDA has announced a virtual public workshop on April 17 from 11:00am – 1:00pm ET to discuss approaches to expand the Accreditation Scheme for Conformity Assessment (ASCA) program. The ASCA program is designed to streamline conformity assessment aspects of medical device review. Currently, ASCA-eligible …

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FDA Proposes Ban on Electrical Stimulation Devices

FDA Proposes Ban on Electrical Stimulation Devices     The FDA has proposed to ban electrical stimulation devices (ESDs) intended for self-injurious or aggressive behavior due to unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling. This is the second time the FDA has proposed …

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Stryker Completes Acquisition of SERF SAS

Stryker Completes Acquisition of SERF SAS     Stryker has completed its acquisition of SERF SAS, a France-based joint replacement company, from Menix. With more than 50 years in the medical device space, SERF SAS is recognized for its innovations in hip implants, including the invention of the original Dual Mobility Cup. In its announcement of …

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Abiomed Updates IFU for Impella Blood Pumps Due to Perforation Risks

Abiomed Updates IFU for Impella Blood Pumps Due to Perforation Risks     The FDA announced that Abiomed is updating the instructions for use (IFU) of its Impella Left Sided Blood Pumps because the pump catheter may perforate the wall of the left ventricle in the heart. During operations, the Impella device could cut through the …

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Make Your Medical Device Pitch For Kids! Announces Grant Winners 

Make Your Medical Device Pitch For Kids! Announces Grant Winners      Rubitection and Kofimi Technology are the winners of the 2024 Make Your Medical Device Pitch for Kids! competition. The Alliance for Pediatric Device Innovation (APDI), an FDA-funded consortium led by Children’s National Hospital, and MedTech Color hosted the most recent edition of the competition, …

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