Back to All Events

How to bring adaptive medical AI systems through MDR and into the clinic

Wednesday 27 May 2026
18:30 21:30

idalab GmbH 68 Potsdamer Straße Berlin, BE, 10785 Deutschland (map)

Google Calendar ICS

Abstract

**Kay Brosien**
Chief Operating Officer
Kintiga

Europe wants AI in healthcare but is the regulatory system ready for it?

At x-cardiac, a Charité spin-off building AI-based medical devices for cardiac surgery, we developed one of Europe's first adaptive AI systems: an algorithm that can be fine-tuned on-site in hospitals and is fully certified under the EU Medical Device Regulation.

The process revealed a system with notified bodies paid by the hour, switching costs of €75,000 for a simple certificate transfer, and a framework that is hard to navigate for start-ups.

In his talk, Kay will map out what it takes to bring adaptive AI through the MDR, and what needs to change if Europe is serious about AI in medicine.

Bio

Kay Brosien is Co-Founder and COO of x-cardiac, a digital health spin-off from the German Heart Center of the Charité and Charité – Universitätsmedizin Berlin. With a background in engineering and fluid dynamics, he has spent over eight years building and certifying AI-based medical devices. At x-cardiac, Kay leads the regulatory strategy for one of Europe's first adaptive AI medical devices, a prognostic algorithm certified under the MDR (class IIa) that can be fine-tuned on-site in hospitals. He is a member of a policy advisory committee for the German Federal Ministry of Research, Technology, and Space.