Of 1,357 FDA-cleared AI devices, only three were tested on patients

Aug 31, 2026 · Issue 5 · 1 source, 1 article

A PLOS Digital Health review finds a validation gap among FDA-cleared AI devices, particularly in anesthesiology and surgery. Of the 1,357 devices, only three were tested on patients.

Who is affected and how

doctor

Clearance of operating-room AI tools does not mean effectiveness has been shown in patients, so clinicians should ask separately for clinical evidence.

medtech company

The lack of clinical validation risks tighter expectations from regulators and buyers.

hospital manager

At procurement, hospitals should ask manufacturers for prospective patient studies.

Narrative: Deployment is faster than evidence

Sources

• FDA cleared 1,357 AI devices. Three were tested on patients.nextinsurgery.com · Aug 31, 2026

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