FDA Approves 87 AI Medical Devices in 2025, Surpassing Total of Previous Three Years

The US FDA has approved 87 AI medical devices in 2025, mainly in radiology (45%), cardiology (12%), pathology (10%), and dermatology (8%). The FDA announced a dedicated post-market surveillance framework for AI medical devices, requiring manufacturers to continuously monitor algorithm performance and report any drift promptly. China's NMPA AI medical device approvals have entered a fast track, with over 120 items approved.