Retail Health Tuesday, September 15, 2026

FDA clears nearly 1,000 AI medical devices by early 2025

The FDA authorized approximately 950 AI/ML-enabled medical devices by early 2025, nearly doubling from 2022, and finalized guidance in December 2024 on Predetermined Change Control Plans to streamline updates for adaptive AI models.

The numbers

~950 FDA-authorized AI/ML devices by mid-2024
~1,000 Authorized devices amid FDA PCCP guidance
100 New authorizations each year
$13.7 billion AI-enabled medical device market value in 2024
$255 billion Projected market value by 2033

Sources

intuitionlabs.ai

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