DeepHealth wins FDA clearance for AI breast ultrasound tool

DeepHealth, Inc., a subsidiary of RadNet, Inc. (NASDAQ: RDNT), has received FDA 510(k) clearance for DeepHealth Breast Ultrasound, an AI-powered tool designed to automate lesion detection, characterization, and reporting in breast ultrasound imaging.

The clearance, issued under 510(k) K260303, covers a device manufactured by See-Mode Technologies Pty Ltd, a DeepHealth company, and distributed in the United States by DeepHealth, Inc. The product is now commercially available for sale in the U.S., with customers able to pursue reimbursement under an existing Category III CPT code for quantitative ultrasound tissue characterization, subject to payer policy.

According to a multi-reader multi-case study involving 16 U.S. board-certified radiologists submitted to the FDA, the tool demonstrated greater than 98% accuracy in localizing breast lesions, an 8% improvement in sensitivity for breast cancer detection, and a 37% reduction in radiologist interpretation time.

RadNet plans to deploy the solution across its network of imaging centers by the end of 2026, estimating that more than 700,000 breast ultrasound studies annually may be eligible for reimbursement.

"Breast ultrasound is an essential component of the breast care pathway, with approximately 40% of women undergoing the exam at some point in their lives," 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."

The product automates lesion measurement extraction, generates radiology reports aligned with ACR BI-RADS standards, and organizes findings in a standardized format intended to reduce manual documentation for sonographers.

DeepHealth Breast Ultrasound joins the company's existing portfolio of breast imaging AI tools, which includes applications for mammography cancer detection, breast density assessment, breast arterial calcification assessment, and mammography quality analytics.

You May Also Be Interested In

• Lexaria signs material transfer agreement with PegBio for GLP-1 study
• Mercer and Compa form alliance to embed pay data in AI workflows
• A10 Networks launches AI gateway for model routing and cost control