USFDAJun 25, 2026, 06:01 AM
RadNet's DeepHealth Gets FDA Clearances for 2 Breast AI Tools
AI Summary
RadNet, Inc.'s wholly owned subsidiary, DeepHealth, Inc., announced it has received FDA 510(k) clearances for two new Breast Suite functionalities: Breast Arterial Calcification (BAC) Assessment and Mammo Dx. BAC Assessment identifies breast arterial calcifications, a potential early indicator of cardiovascular disease, while Mammo Dx integrates prior exams to improve cancer detection rates and reduce recalls. Both functionalities are now commercially available in the United States, enhancing DeepHealth's comprehensive breast imaging AI suite.
Key Highlights
- DeepHealth, a RadNet subsidiary, received FDA 510(k) clearances for two new Breast Suite functionalities.
- BAC Assessment automatically identifies breast arterial calcifications, a potential cardiovascular disease indicator.
- Mammo Dx (formerly ProFound Pro) integrates prior exams to improve cancer detection and reduce recalls.
- Both newly FDA cleared functionalities are now commercially available in the United States.
- BAC Assessment showed over 90% sensitivity and 88% specificity in identifying arterial calcifications.
- The additions reinforce Breast Suite as a comprehensive end-to-end breast imaging AI suite.
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