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ACR® provided comments to the U.S. FDA regarding the draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices.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 three new Transparent-AI products and three new products to the directory.
Three new products were added to our Transparent-AI program, which is designed to increase transparency in imaging AI and help end users have better informed discussions and selection criteria when making decisions about which algorithm might be most appropriate for their local target population.
Perspectum Diagnostics Ltd. joined the Transparent-AI program with their products MRCP+, Hepatica, and LiverMultiScan.
Transparent-AI consists of voluntarily provided data elements solicited from participating imaging AI manufacturers who currently have an FDA-cleared product in the U.S. market. Manufacturers who participate in this program will receive the Transparent-AI badge on their product listing.
Our AI Central directory has also been updated with three new products. This information is pulled directly from FDA 510K documents and updated by ACR staff. With this latest update, we see newly cleared FDA products designed for pediatric x-rays, chest CTs and prostate MR images.
New products include:
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Cardiac CT Function Software Application
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ACR® provided comments to the U.S. FDA regarding the draft guidance to address risk management approaches throughout the lifecycle of AI-enabled medical devices.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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