The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare.
The agency’s AI/ML-Enabled Medical Device List, regularly updated on its website, includes tools across a wide range of specialties such as radiology, cardiology, neurology and anesthesiology.
The list now shows over 1,000 AI-powered medical devices, including dozens of new AI-enabled devices.
In the last six months, FDA Commissioner Marty Makary, MD, has moved quickly to launch and publicize internal AI tools for the agency with the goal of reducing scientific review time.
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