Zenodo
AI medical devices cleared by FDA: 1,000+ in 2024, 75% radiology second opinions, few trials
By Avery Chapman.
Abstract
FDA cleared over 1,000 AI medical devices by 2024, with 75% in radiology for second opinions and triage, mostly validated by retrospective studies, not trials. Independent technical note mirroring the canonical version: https://secondopinionfromai.com/blog/ai-medical-devices-cleared-by-fda-1000-in-2024-75-radiology-second-opinions-few-trials.php
Keywords
- Artificial Intelligence in Healthcare and Education
- AI medical devices
- AI triage
- retrospective validation
- medical AI regulation
- Open access



