Medtech manufacturers and notified bodies must be prepared to allocate significant resource and build their AI expertise now the EU’s AI Act is on the cusp of being adopted.
After 36 hours of negotiation, the Council of the EU and the European Parliament reached a provisional agreement on the EU’s Artificial Intelligence Act. The AI Act is now expected to enter into force in early 2024, with a transition period of two years, as long as final formalities go to plan.
The AI Act is one of the world’s first attempts to address the rapidly evolving technology of AI. It has...
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Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
