A new EU taskforce has been set up to tackle implementation measures as the full extent of urgent actions needed to roll out the new regulations emerge.
An EU Transitional Measures Taskforce has been established to ensure that implementation of the new Medical Device and IVD Regulations is carried out uniformly during the ongoing transition period and that there is no interruption to the supply of safe products
This is one highlight to emerge from the near-final version of the official road map for implementation of new regulations,...
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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.
A proposed rule from Medicare would impact essential devices for many beneficiaries. AdvaMed says the rule would reduce incentives for companies to innovate and criticizes CMS for not providing the necessary information stakeholders need to fully understand the proposal’s implications.
Israeli device firm Fairtility recently obtained US FDA clearance for the CHLOE platform, which uses AI to make embryo assessments performed as part of in vitro fertilization more transparent, efficient and reliable.
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.
