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DeepHealth receives FDA clearance for AI breast suite tools
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DeepHealth receives FDA clearance for AI breast suite tools

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  • DeepHealth, a RadNet (NASDAQ:RDNT) subsidiary, received two FDA 510(k) clearances for its AI-powered Breast Suite features branded as Mammo Dx.
  • The clearances cover BAC Assessment for cardiovascular risk insights and prior exam integration for automated comparison.
  • The tools aim to improve cancer detection, reduce unnecessary recalls, and support more informed clinical decisions.

DeepHealth, a subsidiary of RadNet (NASDAQ:RDNT), received two FDA 510(k) clearances for its AI-powered Breast Suite, branded as Mammo Dx.

The clearances include BAC Assessment, which provides cardiovascular risk insights, and prior exam integration that enables automated comparison with previous studies.

These new capabilities add to the Breast Suite platform to support radiologists in breast imaging workflows.

The tools target improved cancer detection rates, fewer false positives leading to unnecessary recalls, and better-informed clinical decisions through enhanced AI assistance.

DeepHealth’s Mammo Dx features leverage artificial intelligence to analyze breast imaging data more efficiently while incorporating cardiovascular risk information from breast arterial calcification assessment.

RadNet continues to expand its AI capabilities in diagnostic imaging through DeepHealth to enhance accuracy, efficiency, and patient outcomes in women’s health and oncology.

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