AI Act Is Officially Published: Implementation Challenges Ahead For Medtech

Dutch insulin pump maker ViCentra secured $85m to scale European manufacturing, preparing for the 2026 launch of its thinner, lighter Kaleido 2 pump and push into US market. CEO Tom Arnold said the pump has more than 3,500 users in Europe and expects “tens of thousands” in the next 18 months.

Salient's inflammatory bowel disease test, built on the start-up’s Signal platform, is planned to launch in March 2026. The company leverages rich data from existing wellness tests to develop signatures, focusing on conditions that are often misdiagnosed and disproportionately affect women.

The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.

Political and regulatory pressures make revising the EU’s medtech regulations a tricky balancing act, two renowned medtech experts, Erik Vollebregt and Bassil Akra told Medtech Insight during a recent interview.