Regulatory Affairs & FDA
1,451 FDA-Authorized AI/ML Devices — What the Tracker Shows
The FDA has authorized over 1,400 AI/ML-enabled medical devices, with 76% focused on radiology and imaging.
April 22, 2026
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AI/ML devices
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The FDA has authorized over 1,400 AI/ML-enabled medical devices, with 76% focused on radiology and imaging.