Radiology accounted for 68 new FDA-cleared AI algorithms in early 2026, making up more than three-quarters of all AI clinical clearances.
Key Details
- 1FDA's latest update shows 68 new radiology AI algorithms cleared in Q1 2026.
- 2Total FDA-cleared AI algorithms now number 1,524; radiology comprises 1,163 (76.31%).
- 3Including algorithms in other specialties, medical imaging AI approaches 80% of total clearances.
- 4FDA's monthly AI clearances have increased from 21/month in 2024 to around 30/month in 2026.
- 5The RSNA annual meeting features the largest global collection of FDA-cleared AI, with 25% of expo floor dedicated to AI vendors.
Why It Matters
This trend underscores radiology's leading role in clinical AI adoption and regulatory clearance, highlighting rapid ongoing growth and a robust commercial ecosystem. For imaging AI professionals, this signals both opportunity and fierce market competition.
Source
Radiology Business
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