Clairity’s AI Tool for Breast Cancer Risk Gets FDA Green Light

Snippet: The platform uses advanced computer vision to detect imaging features invisible to the human eye, offering personalized risk assessments without relying solely on age or family history.

Clairity, Inc. has received FDA De Novo authorization for CLAIRITY BREAST, a first-of-its-kind AI-powered platform that predicts a woman’s five-year risk of developing breast cancer using only a routine screening mammogram.

The platform uses advanced computer vision to detect imaging features invisible to the human eye, offering personalized risk assessments without relying solely on age or family history — limitations that exclude the majority of breast cancer patients today.

“Now we’re predicting risk of future cancer from patterns in breast tissue, in an otherwise normal screening, before it’s even there,” says Jeff Luber, CEO of Clairity.

Backed by experts from Mass General Brigham and the American Cancer Society, the technology is designed to integrate seamlessly into existing clinical systems.

Clairity plans to launch with leading U.S. health systems through 2025, aiming to scale precision prevention and improve early detection, especially for women often overlooked by traditional models.