Federal Register: FDA Reclassifies AI Cardiac Software to Streamline Market Access for Viz.ai & Tech Developers
September 12, 2026
September 12, 2026
WASHINGTON, Sept. 12 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II. The special controls that apply to t . . .
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Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II. The special controls that apply to t . . .