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

​Abstract

​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.

​​Speaker

​Kay Brosien
Chief Operating Officer
x-cardiac GmbH

​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.

​Agenda

• ​​18:30 - Doors open

• ​​19:00 - Talk starts

• ​​20:00 - Drinks and networking