While there are some warnings that UK medical device companies should be jumping ship, and taking worst-case Brexit scenarios seriously, major notified body BSI believes there is too much scaremongering, and that a less disruptive EU-UK agreement is likely.
There is much confusion and uncertainty around Brexit, which is just 14 months away. But while organizations need to be aware of the worst-case scenarios, there is strong reason to believe the likely outcome will be better, according to Gary Slack, senior VP of global medical devices for notified body BSI.
In particular, Slack says the situation where UK notified bodies will need to set up offices in the EU-27 and...
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.
