healthcare.digital January 23, 2026
European HealthTech this week is being shaped by fresh EU-level funding calls for digital health and AI, tightening but slightly simplified device and AI regulation, and continued emphasis on compliance‑driven M&A and scaling of AI decision‑support. Capital is available but flowing selectively into data‑rich platforms, cross‑border care models, and AI‑enabled diagnostics that can navigate the emerging AI Act / MDR / HTA stack.
Policy and regulatory moves
The EU’s 2026 Health Technology Assessment work programme is ramping up, with around 50 joint clinical assessments planned for medicines and high‑risk devices, raising the bar for evidence and pan‑EU launch planning.
Draft MDR/IVDR simplification removes the five‑year certificate validity cap and shifts toward continuous, risk‑based surveillance, aiming to ease bottlenecks while tightening...
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