After a hiatus of nearly a year, the EU can celebrate another designation under the IVD Regulation.
The Istituto Superiore di Sanita, based in Rome, has become Italy’s first - and the EU’s 13th - organization to be designated as a notified body to assess products that fall under the scope of the IVD Regulation.
It is a familiar organization to the medtech world; it is already designated under the Medical Device Regulation (MDR) and...
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
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.
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.
