Retail Health Wednesday, September 9, 2026

FDA clears record 295 AI medical devices in 2025

The FDA cleared 295 AI/ML-enabled medical devices from 221 manufacturers in 2025, with 62% classified as Software as a Medical Device and a median review time of 142 days.

The numbers

295 Total FDA clearances for AI/ML medical devices in 2025
221 Number of unique manufacturers with cleared AI/ML devices
62% Percentage of clearances classified as Software as a Medical Device
142 days Median clearance time for AI/ML medical devices
63% Percentage of cleared devices designed for diagnostic purposes

Sources

innolitics.com

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