Alan Fraser and Stefan James on the CORE-MD recommendations for high-risk medical devices

Alan Fraser and Stefan James talk to Acting Deputy Editor Heather Brown about the evidence needed for regulatory approval of high-risk medical devices, such as stents, valves, pacemakers, and orthopaedic implants. The CORE-MD project makes recommendations for what evidence should be needed and calls for greater transparency and predictability.

Click here to read the full article: https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(25)00252-2/fulltext