FDA-cleared radiology AI devices rose by 42% between 2023 and 2025, now totaling over 1,000 approved tools.
Key Details
- 1Analysis published in Academic Radiology reviews FDA's AI-enabled device database.
- 21,094 radiology-specific AI devices authorized by FDA through December 2025.
- 3Annual authorizations for radiology AI rose by 42% from 2023 to 2025.
- 4Radiology remains the leading field for FDA-cleared AI medical devices.
- 5Device functions, clinical applications, and regulatory profiles were categorized by the study team.
Why It Matters
Rapid growth in FDA-cleared AI radiology devices signals increasing market availability, influencing procurement and clinical integration strategies. Updated regulatory insights support informed decision-making and point to ongoing areas for research and development.
Source
Radiology Business
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