DeepHealth Receives Two FDA Clearances Enabling it to Add Cardiovascular Insights and Prior Exam Integration to its AI-Powered Breast Suite
Rhea-AI Summary
DeepHealth, a RadNet (NASDAQ: RDNT) subsidiary, received two FDA 510(k) clearances for its AI-powered Breast Suite: BAC Assessment and prior exam integration, branded Mammo Dx.
The tools add cardiovascular risk insights and automated prior-study comparison, targeting improved cancer detection, fewer recalls, and better-informed decisions.
Positive
- Two new FDA 510(k) clearances for BAC Assessment and Mammo Dx
- BAC Assessment sensitivity above 90% and specificity above 88% in testing
- New tools now commercially available in the United States
- BAC Assessment to be deployed across RadNet imaging centers for real-world validation
- Breast Suite components used across more than 10 million mammograms annually worldwide
Negative
- None.
News Market Reaction – RDNT
In the Jun 25 session, RDNT gained 3.18%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 10 | Debt financing | Positive | +0.1% | Incremental $250M term loan with lower rates to support growth initiatives. |
| Jun 10 | AI product launch | Positive | +3.5% | Launch of Reporting Pro AI radiology platform in US and UK markets. |
| Jun 03 | Debt financing proposal | Positive | -4.5% | Proposed $200M incremental term loan to fund strategic growth opportunities. |
| May 28 | Educational outreach | Positive | +2.7% | Announcement of free public Men’s Health webinar on imaging and screening. |
| May 10 | Earnings and guidance | Positive | -3.9% | Record Q1 results and raised 2026 imaging center revenue and EBITDA guidance. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
RDNT’s news flow has produced mixed price reactions, with several strong moves both up and down following strategic and financial updates.
Key Terms
510(k) clearances regulatory
breast arterial calcifications medical
ffdm medical
dbt medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
New capabilities are designed to improve cancer detection and recall rates and enable physicians to make informed cardiovascular decisions
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
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.
Forward Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the safe harbour provisions of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as: “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “outlook,” “plan,” “potential,” “possible,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would,” the negative of these words, and similar references to future periods. Examples of forward-looking statements include statements regarding our technology’s ability to stage-shift disease through proactive, timely intervention and discussions regarding our product features. Actual results could differ materially from those currently anticipated due to a number of risks and uncertainties, many of which are beyond RadNet’s control.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on management’s current beliefs, expectations and assumptions regarding the future of RadNet’s business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of RadNet’s control. RadNet’s actual results and financial condition may differ materially from those indicated in the forward-looking statements as a result of various factors. Neither RadNet, nor any of its directors, executive officers, or advisors, provide any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements will actually occur, or if any of them do occur, what impact they will have on the business, results of operations or financial condition of RadNet. Should any risks and uncertainties develop into actual events, these developments could have a material adverse effect on RadNet’s business and the ability to realize the expected benefits of the technology. Risks and uncertainties that could cause results to differ from expectations include, but are not limited to: (1) the ability to recognize the anticipated benefits of the technology, and (2) the risk of legislative, regulatory, economic, competitive, and technological changes, and other risks and uncertainties described in the “Risk Factors,” “Management’s Discussion and Analysis,” and other sections of our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The foregoing review of important factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included elsewhere. Additional information concerning risks, uncertainties and assumptions can be found in RadNet’s filings with the Securities and Exchange Commission (the “SEC”), including the risk factors discussed in RadNet’s most recent Annual Report on Form 10-K, as updated by its Quarterly Reports on Form 10-Q and future filings with the SEC.
Forward-looking statements included herein are made only as of the date hereof and, except as required by applicable law, RadNet does not undertake any obligation to update any forward-looking statements, or any other information in this communication, as a result of new information, future developments or otherwise, or to correct any inaccuracies or omissions in them which become apparent. All forward-looking statements in this communication are qualified in their entirety by this cautionary statement.
DeepHealth Media Contact
Andra Axente
Director of Communications
+31614440971
andra.axente@deephealth.com
RadNet Media Contacts
Jane Mazur
Senior Vice President, Corporate Communications
+1 585-355-5978
jane.mazur@radnet.com
Mark Stolper
Executive Vice President and Chief Financial Officer
+1 310-445-2800
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.
