FDA has now cleared more than 1,000 AI models, including many in cardiology January 10, 2025 |
FDA has now cleared more than 1,000 AI models, including many in cardiology
January 10, 2025 |
Summary:
The FDA has approved over 1,000 AI algorithms for clinical use in the U.S., with cardiology ranking second with 161 approvals. Radiology leads with 758 algorithms, while neurology follows with 35. The FDA clears around 20 AI algorithms monthly, a number expected to rise. Recent approvals include 10 cardiology-specific AI tools such as EchoGo Heart Failure and HeartKey Rhythm, which aid in diagnostics like heart failure detection and arrhythmia analysis. Other approved tools include AI for fluid management, calcium scoring, and cardiac ultrasound automation.
