AI mammography, prostate imaging algorithms cleared for market

The FDA has OK’d two subsidiaries of Los Angeles-based RadNet to sell medical AI software—one product for diagnosing breast cancer, the other for streamlining MRI prostate reporting workflows.

RadNet subsidiary DeepHealth, based in Cambridge, Mass., got the go-ahead for its Saige-Dx mammography offering. RadNet says this is a next generation of DeepHealth’s Saige-Q worklist triage software.

The updated technology automatically identifies suspicious lesions in mammograms and assigns a suspicion level to each finding and to the entire case, helping “detect and diagnose breast cancer earlier while reducing unnecessary recalls,” according to an announcement.

Meanwhile RadNet subsidiary Quantib received FDA’s blessing for an updated iteration of Quantib Prostate, an AI-based software suite of tools for use with MRI, that newly includes “fully automatic prostate zone segmentation (in addition to prostate gland segmentation) and automated initiation of localization of lesions on the PI-RADS sector map.”

RadNet CEO and co-founder Howard Berger, MD, places the approvals in the context of U.S. medicine’s decades-long war on cancer.

“The Biden administration, through its Cancer Moonshot program, is committed to significantly reducing the mortality rates from cancer in the coming decades,” Berger says. “We believe these AI tools will play an important role in the early detection and diagnosis of cancer, resulting in improved survival rates and better patient outcomes.”

Full announcement here.

Dave Pearson

Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.

Trimed Popup
Trimed Popup