P4LPrevention for LongevityEvidence → Decision → Adoption

Evidence Explorer · EV-022

AI-enabled medical devices

FDA maintains a public list identifying AI-enabled medical devices authorized for marketing in the United States.

E5100/100 confidenceFederal authorization landscape

What this evidence supports

FDA's AI-enabled device list provides a public baseline of authorized medical AI devices.

What it does not establish

Inclusion on the list reflects marketing authorization; it does not establish comparative effectiveness or widespread clinical adoption.

Record details

Source authority
FDA
Evidence level
E5
Directness
5/5
Recency
5/5
Decision relevance
5/5
Date
2026-07-01

Primary source

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Related intelligence

FDA's AI-enabled medical-device list remains a current transparency and landscape resource