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DeepHealth Receives FDA Clearances For New AI-Powered Breast Imaging Tools
By RTTNews Staff Writer ✉
| Published: 6/25/2026 6:38 AM ET
Addas your preferred news source on Google
DeepHealth, Inc., an AI-powered health informatics company and a unit of RadNet, Inc. (RDNT), said Thursday it received U.S. FDA 510(k) clearances for two new functionalities in its Breast Suite platform.
The newly cleared tools include Breast Arterial Calcification (BAC) Assessment, which automatically detects breast arterial calcifications on routine screening mammograms. Such calcifications may serve as an early indicator of cardiovascular disease.
The FDA also cleared prior exam integration for ProFound Pro, DeepHealth’s AI-powered cancer detection application, enabling automatic comparison of current and previous mammograms to track existing lesions and identify new ones. The functionality is designed to improve cancer detection and reduce patient recall rates. The product will be marketed as Mammo Dx.
Both newly cleared functionalities are now commercially available in the United States, the company said.
RadNet shares were up more than 1% in pre-market trading after closing at $58.16 on Wednesday.
For comments and feedback contact: editorial@rttnews.com
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