ClearanceIQ FDA AI Device Intelligence
Live FDA Data · 1995–2026

The FDA has cleared

— AI-powered medical devices

92% of them cleared in the last 6 years. Here's what the data actually looks like.

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—
Total AI devices cleared
since 1995
—
Cleared in 2025
record year
—
Go through 510(k)
not PMA or De Novo
—
Are radiology devices
most dominant specialty

Key Takeaways

AI Device Clearances by Year

Showing 2015–2026 · 2026 is year-to-date

Regulatory Pathways

510(k), De Novo, PMA

Where AI Is Being Adopted

By medical specialty

Companies With the Most FDA AI Clearances

Top 10 by total clearances · all time

Data Source

Data sourced from the FDA's publicly available Artificial Intelligence-Enabled Medical Device database . Dataset covers all FDA-cleared AI/ML-enabled medical devices from 1995 through mid-2026.

Clearance pathway determined by submission number prefix: K = 510(k), DEN = De Novo, P = PMA.

About the Creator

Built by Ahmed Nour, a regulatory and product operations professional with experience across Abbott Diabetes Care (FreeStyle Libre, Lingo CGM platforms), Genentech, and BioMarin.

ClearanceIQ was created to make FDA AI/ML clearance data accessible to founders, product managers, and investors navigating the digital health landscape.