EU AI Act meets MDR/IVDR: clarity or chaos?

Lucida Medical raises $11.4m to advance AI prostate cancer diagnostic ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏  ͏ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­  

Share with friend    View in browser DECODED Medical Devices March 31, 2026 SPOTLIGHT READ EU AI Act meets MDR/IVDR: clarity or chaos? Observers anticipate that the EC's proposal to harmonise the AI Act's tenets for medical devices with the MDR/IVDR could be adopted by summer 2026. LATEST NEWS IN YOUR INDUSTRY Lucida Medical raises $11.4m to advance AI prostate cancer diagnostic Lucida's software is designed to identify prostate cancer 'within minutes' and overcome diagnosis delays associated with worse patient outcomes.   FDA approves Anumana's pulmonary hypertension algorithm The algorithm integrates with EHR systems and ECG platforms, operating within the health system without external data transfer.   Abbott integrates Precision Oncology portfolio into Flatiron's OncoEMR The integration supports treatment decisions across cancer care stages and helps reduce administrative tasks for clinicians.   FDA clears Medtronic's Stealth Axis system for cranial and ENT procedures Medtronic views Stealth Axis as the 'cornerstone' of AiBLE, the company's surgical workflow ecosystem.   Why some companies have left cell and gene therapy behind in 2025 In this epsiode, Pharmaceutical Technology editor, Robert Barrie, talks with Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, about the current state of the sector and what's in store next. Listen Now JP Morgan Healthcare Conference 2026: Post-Congress Report GlobalData's analyst and journalist teams have published a post-congress JPM 2026 report, distilling the most important announcements, deal activity, and strategic themes from the conference. Access the report Expand your subscription to other sectors   Subscribe to our other newsletters here. Was this email forwarded to you? Sign up here. Prefer a podcast? Instant Insights ranks in the top 10% of podcasts globally - follow us on Spotify, Apple, YouTube, and Amazon Music.   What keeps your CEO up at night? Generative AI, ESG, and disruptive technologies.  What is thematic intelligence and why do business executives need it?   Predict the future Find business opportunities based on 150 million+ signals showing what your customers and competitors will do in the next 5 years. GlobalData  At GlobalData we have a proven track record in helping thousands of companies, government organizations, and industry professionals benefit from faster, more informed decisions. You can update your communication preferences to make sure you receive the right information for you.  GlobalData, John Carpenter House | Registered in England No. 03925319, John Carpenter Street, London, EC4Y 0AN, United Kingdom   Unsubscribe  |   Manage Preferences London