Enhancements to FDA Draft AI Guidance
ACR® provided comments to the U.S. FDA regarding the draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices.
Read moreACR Data Science Institute’s AI Central has been updated with 6 new products to the directory.
Our AI Central directory has also been updated with 6 new products. This information is pulled directly from FDA 510K documents and updated by ACR staff. With this latest update, we see many newly cleared FDA products designed for chest ultrasounds and CT scans.
New products include:
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
InVision Precision LVEF (LVEF)
Enhancements to FDA Draft AI Guidance
ACR® provided comments to the U.S. FDA regarding the draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices.
Read moreProhibition on Discrimination
Covered entities must make reasonable efforts to identify uses of patient care decision support tools in their health programs and activities that employ input variables or factors that measure race, color, national origin, sex, age or disability.
Read moreACR Provides Input on AI Action Plan
ACR focused AI oversight, transparency, post-deployment monitoring, and other medical uses of AI.
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