AI-Powered Breast Ultrasound Receives FDA Clearance

July 30, 2026 — DeepHealth, Inc. has received FDA 510(k) clearance for DeepHealth Breast Ultrasound¹, an AI-powered solution that brings greater standardization, clinical accuracy and efficiency to breast ultrasound imaging.  DeepHealth Breast Ultrasound automates lesion detection, characterization and reporting, streamlining sonographer and radiologist workflows in one intelligent experience.  Together with its AI-powered mammography solutions, the expanded DeepHealth breast platform is the most comprehensive in the industry.

In addition to a multi-reader multi-case study involving 16 U.S. board-certified radiologists at select imaging centers and hospitals², RadNet has validated the effectiveness of DeepHealth Breast Ultrasound in live clinical settings under regulated research protocols.  Now with FDA clearance, DeepHealth Breast Ultrasound is commercially available for sale to customers in the United States who can pursue reimbursement under an existing Category III CPT code for quantitative ultrasound tissue characterization³.  By the end of this year, the solution will be implemented across RadNet’s network of centers, with an estimated more than 700,000 breast ultrasound studies annually that may be eligible for reimbursement.

Breast Ultrasound

“Breast ultrasound is an essential component of the breast care pathway, with approximately 40% of women undergoing the exam at some point in their lives⁴.  It is a highly complex, operator-dependent examination, which can lead to significant variability in image acquisition, interpretation and reporting,” said Dr. Jason McKellop, Medical Director of Women’s Imaging for RadNet California.  “With DeepHealth’s breast ultrasound solution, we can achieve greater standardization of workflows, improving consistency while saving time for patients, sonographers and radiologists.  By streamlining the examination process, we can help reduce exam times, enhance efficiency and ultimately improve patient outcomes.”

DeepHealth Breast Ultrasound is designed to support more efficient and standardized ultrasound workflows through:

• Automated lesion detection – Assists the interpreting physician to localize the presence or absence of suspicious soft-tissue lesionsin standard ultrasound breast images, with demonstrated greater than 98% accuracy in localizing breast lesions and improved sensitivity for breast cancer detection by 8%2

• Automated lesion characterization – Analyzes images acquired by the sonographer to assist the interpreting physician in generating and characterizing the lesion shape, orientation, margin, echo pattern and posterior features, in line with ACR BI-RADS, reducing radiologist interpretation time by 37%2

• Automated reporting – Generates a comprehensive radiology report of the key findings and impressions, helping radiologists move more efficiently from image review to final report while retaining control of the final assessment

• Expedited sonographer workflow – Automatically extracts and organizes lesion measurements, characteristics and other relevant findings in a standardized format, reducing manual documentation for sonographers with the aim of reducing overall exam time

“No single imaging pathway addresses every woman’s needs.  With the addition of Breast Ultrasound, we are proud to support women across a broader range of screening and diagnostic pathways, including those with dense breasts and others who may require supplemental imaging.  Bringing together AI-powered capabilities across mammography and ultrasound helps clinicians respond to different imaging needs and deliver more comprehensive, personalized breast care,” said Niccolò Stefani, M.D., Business and Product Leader, Clinical AI at DeepHealth.

DeepHealth’s breast imaging platform⁵ — a modular, interoperable AI-powered portfolio addressing real-world clinical needs across breast cancer screening and diagnostic pathways — includes applications for cancer detection in both mammography and ultrasound, density assessment, breast arterial calcification assessment, image-based breast cancer risk prediction⁶ and mammography quality analytics, with viewing and reporting tools for improved operational efficiency.

References

1. Deephealth Breast Ultrasound is the commercial name for the See-Mode Augmented Reporting Tool, Breast (SMART-B) device, cleared by the FDA under 510(k) K260303. The clearance is held by See-Mode Technologies Pty Ltd, a DeepHealth company, which manufactures the device; it is distributed in the United States by DeepHealth, Inc.
2. Data on file. Based on data from MRMC study submitted to FDA for 510(k) clearance K260303.
3. Reimbursement depends on payer policy.
4. Based on change of regulations and gold-standard approach in breast cancer screening. U.S. Food and Drug Administration. Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide—Guidance for Industry and Food and Drug Administration Staff. Issued August 26, 2024, www.fda.gov/media/181152/download.
5. U.S. Food and Drug Administration. Understanding Breast Density. FDA Office of Women’s Health. www.fda.gov/consumers/womens-health-topics/understanding-breast-density
6. DeepHealth breast solutions comprise multiple applications, including Mammo Dx, Breast Density, Safeguard Review, Risk Assessment, BAC Assessment, Mammography Insight, Breast Ultrasound and workflow tools including DeepHealth Viewer. DeepHealth Viewer is manufactured by eRAD, Inc. and distributed by DeepHealth, Inc. Mammography Insights is manufactured by Aquila, Inc. and distributed by DeepHealth, Inc.
7. Not cleared for use in the U.S. Capability available in Europe.