Industry will be well acquainted with the proposal's content since it reflects its own work on the much-needed further development of the Medical Device Regulation
The European Parliament has drafted a proposal for an amending regulation to the Medical Device Regulation laying out – among other things - how a new European Medical Device Office should be created and what its role should be.
The Parliament has also suggested specific procedures for conformity assessment of orphan and innovative devices, among other far-reaching changes.
Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.
Without change, the implementation of the MDR and IVDR could hit another wall.
Evolution of the MHRA and its offering to medtechs continues, with the hunt for a visionary chief medical and scientific officer and release of outline plans on early access to innovative devices, building on IDAP learnings.
Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."
The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.
Without change, the implementation of the MDR and IVDR could hit another wall.
Evolution of the MHRA and its offering to medtechs continues, with the hunt for a visionary chief medical and scientific officer and release of outline plans on early access to innovative devices, building on IDAP learnings.
