Cardiovascular Business January 17, 2025
Cardiology has approximately 160 of the 1,000 U.S. Food and Drug Administration (FDA)-cleared clinical artificial intelligence (AI) algorithms, ranking it No. 2 among healthcare specialties behind radiology. This ongoing trend was a major topic at the FDA Town Hall sessions during the
Transcatheter Cardiovascular Therapeutics (TCT) 2024 meeting
“The FDA is super excited and thrilled about the number of device manufacturers that are using AI to enable their devices, and the fact that a number of those devices are starting to achieve market authorization,” Stephen Browning, the agency’s assistant director for hemodynamics and heart failure diagnostics, told Cardiovascular Business.
Browning spoke in the FDA Town Hall sessions about the agency’s evolving perspectives and regulatory strategies for AI-enabled cardiovascular devices. His...
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