DeepHealth Receives Two FDA Clearances Enabling it to Add Cardiovascular Insights and Prior Exam Integration to its AI-Powered Breast Suite
SOMERVILLE, Mass., June 25, 2026 (GLOBE NEWSWIRE) -- DeepHealth, Inc., a leader in AI-powered health informatics and a wholly owned subsidiary of RadNet, Inc. (NASDAQ:RDNT), announces it has received FDA 510(k) clearances for two new Breast Suite1 functionalities:
- Breast Arterial Calcification (BAC) Assessment, a tool applied to standard screening mammograms that automatically identifies breast arterial calcifications, a potential early indicator of cardiovascular disease;2
- Prior exam integration into ProFound Pro, which enables automatic processing of prior and current studies to track prior lesions and distinguish new lesions, with the goal of improving cancer detection rates and reducing recalls. ProFound Pro with prior exam integration will be brought to market as Mammo Dx.3
The two additions reinforce Breast Suite as the industry’s most comprehensive end-to-end breast imaging AI suite—a modular, interoperable portfolio of applications addressing real-world clinical needs across breast cancer screening and diagnostic pathways. Both newly FDA cleared functionalities are now commercially available in the United States.
"Our strategy has always centered around using AI to find disease early. BAC Assessment and Mammo Dx are proof points of that strategy: one adds a cardiovascular evaluation to a routine breast cancer screening mammogram and the other incorporates changes from past mammogram exams into current mammograms to improve cancer detection. Together, they transform Breast Suite into a fully integrated suite of solutions that give radiologists a more complete patient overview and added clinical confidence in two of the top causes of death in U.S. women," said Niccolo Stefani, MD, Business and Product Leader, Population Health & Clinical AI, DeepHealth.
BAC Assessment analyzes standard 2D (FFDM) and 3D (DBT) mammograms, automatically identifying and flagging breast arterial calcifications within the radiology workflow with no additional imaging required beyond the mammogram. BACs visible on mammograms have been linked to an elevated risk of future cardiovascular events, including heart attacks and strokes.2 In clinical performance testing, DeepHealth’s BAC Assessment demonstrated more than 90% sensitivity and more than 88% specificity in identifying arterial calcifications across both dense and non-dense breast tissue.4 BAC Assessment is now commercially available and will be deployed across RadNet imaging centers in the U.S., providing additional real-world validation of its capability.
With the addition of prior exams, Mammo Dx enables the comparison of breast tissue over time amongst prior and current exams and helps radiologists identify subtle changes with lesions that may be undetected on a single-exam read. Mammo Dx brings prior findings into the interpretation process, supporting more informed clinical decision-making with the ultimate goal of helping reduce false positives and better determining when additional diagnostic procedures may be warranted.
With these clearances, DeepHealth’s Breast Suite now includes BAC Assessment, Mammo Dx for cancer detection and diagnosis, automated breast density assessment and future cancer risk assessment,5 alongside workflow tools that elevate radiologist performance and enhance operational efficiency. Today, components of Breast Suite support diagnostic accuracy6 and standardization of care7 across more than 10 million mammograms performed annually across the world.
About DeepHealth
DeepHealth is a wholly owned subsidiary of RadNet, Inc. (NASDAQ:RDNT) and serves as the umbrella brand for RadNet’s Digital Health segment. DeepHealth provides AI-powered health informatics with the aim of empowering breakthroughs in care through imaging. DeepHealth leverages advanced AI for operational efficiency and improved clinical outcomes in breast, chest, musculoskeletal, neuro, prostate and thyroid health. At the heart of DeepHealth’s portfolio is a cloud-native operating system – DeepHealth OS – that unifies data across the clinical and operational workflow. Thousands of imaging centers and radiology departments around the world use DeepHealth solutions to enable earlier, more reliable and more efficient disease detection, including in large-scale cancer screening programs. DeepHealth’s human-centered, intuitive technology aims to push the boundaries of what’s possible in healthcare. Learn more at deephealth.com.
About RadNet, Inc.
RadNet, Inc. is a leading national provider of freestanding, fixed-site diagnostic imaging services in the United States based on the number of locations and annual imaging revenue. RadNet has a network of owned and/or operated outpatient imaging centers. RadNet’s imaging center markets include Arizona, California, Delaware, Florida, Idaho, Indiana, Maryland, New Jersey, New York, Texas and Virginia. In addition, RadNet provides radiology information technology and artificial intelligence solutions marketed under the DeepHealth brand, teleradiology professional services and other related products and services to customers in the diagnostic imaging industry globally. Together with contracted radiologists, and inclusive of full-time and per diem employees and technologists, RadNet has over 11,000 team members. Learn more at radnet.com.
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DeepHealth Media Contact
Andra Axente
Director of Communications
+31614440971
andra.axente@deephealth.com
RadNet Media Contacts
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jane.mazur@radnet.com
Mark Stolper
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References
- Breast Suite comprises multiple applications, including Mammo Dx, Breast Density, Safeguard Review, Risk Assessment, BAC Assessment, DeepHealth Viewer, Mammography Insights and Breast Ultrasound. DeepHealth Viewer is manufactured by eRAD, Inc. and distributed by DeepHealth, Inc. Mammography Insights is manufactured by Aquila, Inc. and distributed by DeepHealth, Inc. Any claims made about Breast Suite may reference claims associated with its individual components.
- Nandurkar et al., "Breast Arterial Calcification as a Predictor for Future Cardiovascular Events and Mortality: A Systematic Review and Meta-analysis," Journal of Breast Imaging, 2026.
- The FDA-cleared software previously known as ProFound Pro is now marketed as Mammo Dx including priors. Mammo Dx retains the FDA-cleared capabilities of ProFound Pro and serves as the foundation for ongoing innovation, with additional features and enhancements being introduced over time.
- FDA 510(k) clearance K254131. Clinical Performance Testing.
- Not cleared for use in the U.S. Capability available in Europe.
- Louis, L. et al. "Equitable Impact of an AI-Driven Breast Cancer Screening Workflow in Real World US-wide Deployment." Nature Health, 2025.
- McCabe et al. "Multistage AI-Driven Workflow Improves General Radiologist Screening Mammography Performance to the Level of Fellowship-Trained Breast Imagers: Real-world Evidence in >500,000 Patients." RSNA Chicago. 2025.
