The U.S. Food and Drug Administration (FDA) has recently authorised over 100 artificial intelligence (AI)-enabled medical devices across a broad range of clinical applications, reflecting the accelerating integration of machine learning and software-based diagnostics into healthcare. The newly cleared devices, which include AI-driven tools for radiology, cardiology, neurology, and reproductive medicine, aim to enhance diagnostic accuracy, speed up clinical workflows, and support personalised care.

Major contributors include Aidoc, Hyperfine, Roche Molecular, GE Healthcare, and Pearl Inc., with innovations ranging from portable MRI systems and lymphoma detection tools to semen quality analysers and cardiac amyloidosis diagnostics. These approvals reinforce the FDA’s commitment to promoting trustworthy AI adoption in medical devices while maintaining rigorous safety and efficacy standards.

AI-Enabled Medical Devices: 100 Most Recent FDA Clearances (2025)