In this episode of Medtech Connect, Medtech Insight senior regulatory writer Eliza Slawther interviews MedTech Europe’s digital lead Alexander Olbrechts about the interplay between EU medical device laws with proposed horizontal regulations that impact digital devices, such as the AI Act, the Data Act and the European Health Data Space. The importance of international harmonized standards, particularly for cybersecurity, is also discussed.
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"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
