In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.
The latest notified body designated under the EU’s Medical Device Regulation, Scarlet NB, based in the Netherlands, specializes in certifying medical software.
Its bold name is sufficient to draw attention, but the fact it is focused on one area is unusual.
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.
