Source: FDA AI/ML-Enabled Medical Devices list (annual tallies from published analyses) · retrieved 2026-05-31
Discussed in: Chapter 6: Artificial Intelligence in Healthcare
← Data
FDA AI/ML-enabled medical device authorisations per year
Number of AI/ML-enabled medical devices the FDA authorised each year. Annual authorisations rose from single digits in the late 2010s to a record 295 in 2025; cumulative authorisations passed 1,000 in 2024 and reached roughly 1,450 by the end of 2025.