In the EU, there are now six EU notified bodies designated under the IVD Regulation.
French notified body, GMed, has been designated under the IVD Regulation for a comprehensive scope of products.
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Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.
Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.
As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
FDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.
New continuous glucose monitoring manufacturing site in Indiana is part of Roche’s plan to boost its US presence. Roche’s launch of Accu-Chek SmartGuide system last year with AI-powered prediction capabilities puts it as a key differentiator from competitors such as Abbott and Dexcom.
As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.
