FDA Clears First AI Tool to Predict 5-Year Breast Cancer Risk Using Mammograms Alone

The U.S. Food and Drug Administration has granted its first de novo authorization for an artificial intelligence-based tool designed to predict a woman's five-year risk of developing breast cancer using only standard screening mammograms, the company behind the product announced on May 30.

Developed by the Boston-based firm Clairity, the tool—called Clairity Breast—analyzes mammogram images to identify subtle patterns that may not be visible to the human eye, offering radiologists a validated five-year risk score through existing clinical systems.

Most traditional risk models rely heavily on factors like age and family history, but these are limited: approximately 85% of women diagnosed with breast cancer have no family history, and about half lack any known risk indicators. Clairity’s AI aims to fill this gap by examining image-based features that correlate with future cancer risk.

"Clairity’s FDA authorization is a turning point for more women to access the scientific advances of AI-driven cancer risk prediction,” said Dr. Larry Norton, founding scientific director of the Breast Cancer Research Foundation and oncologist at Memorial Sloan Kettering. “Breast cancer is rising, especially among younger women, yet most risk models often miss those who will develop the disease. Now we can ensure more women get the right care at the right time.”

Clairity Breast was founded in 2020 by Dr. Constance “Connie” Lehman, a Harvard professor and former chief of breast imaging at Massachusetts General Hospital. The startup is supported by Santé Ventures and ACE Global Venture. According to the company, Clairity Breast has been trained on millions of mammogram images paired with five-year follow-up data, helping it learn to detect pixel-level signs of potential cancer development.

“Advancements in AI and computer vision can uncover hidden clues in the mammograms—often invisible to the human eye—to help predict future risk,” said Lehman.

Company CEO Jeff Luber highlighted the technology’s ability to fit into current workflows while offering a new level of precision prevention. “What makes the availability of Clairity Breast a true sea change is that we’re now anticipating cancer from patterns in breast tissue, in an otherwise normal screening, before it’s even there,” Luber said. He added that the goal is to help providers reduce late-stage cancer diagnoses, lower healthcare costs, and ultimately save lives.

Clairity plans to commercially launch the product by the end of 2025.

While the FDA has previously approved AI tools to assist in breast cancer detection and risk management, this is the first to receive authorization specifically for predicting five-year risk directly from screening mammograms. The announcement follows recent industry trends, including RadNet Inc.’s acquisition of iCAD and emerging research—such as a study in RSNA’s Radiology—exploring risk prediction from negative mammograms.