New video: AI-Driven Fracture Risk, Built for EU Compliance with Christophe Amiel

METASTRA has released a new interview outlining how its Decision Support System (DSS) for patients with vertebral metastases is being designed with regulatory and quality requirements in mind from the outset. The DSS combines biomechanically informed modelling with AI to support surgeons’ treatment decisions, with a long-term pathway toward certification.

“What I’ve seen here is rare: teams are factoring regulatory, quality and AI Act considerations very early, not only the science,” says Christophe Amiel, adding that this approach aims to avoid re-work and expedite CE-marking and access for physicians and patients.

The interview highlights added requirements typical for SaMD, including cybersecurity, interoperability in hospital settings, and AI-specific evidence and risk assessments as the EU AI Act enters into force.

Watch the interview with Christophe Amiel here.