Assessing the chemical makeup of a medical device as part of the safety evaluation can either be a blessing for manufacturers by shortening the time to market or entail some surprises, according to ...
Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
A GPT-powered medical device certified in Europe raises questions about generative AI in health care
Last fall, a group of experts advising the U.S. Food and Drug Administration debated for two days on how to regulate generative artificial intelligence tools in medicine. One report presented at the ...
Bloggers at the Millennium Research Group’s blog compared the FDA and the European CE mark and the effects on innovation in both markets. According to industry experts the MRG authors interviewed, the ...
Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
Merit Medical Systems, Inc. announced that its WRAPSODY® Cell-Impermeable Endoprosthesis has received premarket approval from the FDA, allowing for commercialization in the U.S. starting in 2025. This ...
Safety issues occur more often in medical devices first approved by the European Union when compared to devices first approved in the U.S., according to a recent study published in The BMJ. In the EU, ...
Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted Cochlear Implant has been approved by the U.S. Food and ...
South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...
Medical Device Network on MSN
Edwards receives FDA approval for mitral valve replacement system
Edwards Lifesciences has received the US Food and Drug Administration (FDA) approval for its SAPIEN M3 mitral valve ...
Technology announced that its subsidiary, Hunan Saitumofei received manufacturing approval from the Hunan Provincial Medical ...
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