FDA approves first AI tool to predict breast cancer risk

Fox News

03-06-2025

The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk.
The authorization was confirmed by digital health tech company Clairity, the developer of Clairity Breast – a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram.
In a press release, Clairity shared its plans to launch the AI platform across health systems through 2025.
Most risk assessment models for breast cancer rely heavily on age and family history, according to Clairity.
However, about 85% of cases occur in women who have no family history of breast cancer, likely stemming from genetic mutations that occur because of aging, health agencies report.
Traditional risk models have also been built on data from predominantly European Caucasian women, which Clairity said has not been "generalized well" to diverse backgrounds.
The AI tool analyzes subtle images from a screening mammogram that correlate with breast cancer risk, then generates a "validated five-year risk score" and delivers it to healthcare providers, the company noted.
Dr. Connie Lehman, Clairity founder and breast imaging specialist at Mass General Brigham, stressed the importance of mammograms in early cancer detection.
"Now, advancements in AI and computer vision can uncover hidden clues in the mammograms – invisible to the human eye – to help predict future risk," she said in a press release.
"By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere."
Dr. Robert A. Smith, senior vice president of early cancer detection science at the American Cancer Society, also commented in a statement that personalized, risk-based screening is "critical to improving breast cancer outcomes, and AI tools offer us the best opportunity to fulfill that potential."
"This is the wave of the future. AI is going to be part of the equation, but it's not going to take over."
"Clairity's FDA authorization is a turning point for more women to access the scientific advances of AI-driven cancer risk prediction," Larry Norton, founding scientific director of the Breast Cancer Research Foundation, wrote in another statement.
"Breast cancer is rising, especially among younger women, yet most risk models often miss those who will develop the disease," he said. "Now we can ensure more women get the right care at the right time."
More than 2.3 million women are diagnosed with breast cancer globally each year, including more than 370,000 in the U.S., despite "decades of progress," according to the Breast Cancer Research Foundation.
Cases have particularly been on the rise among younger women under the age of 50.
In a Tuesday appearance on "America's Newsroom," Fox News senior medical analyst Dr. Marc Siegel called Clairity's development "profound."
"Just looking at a mammogram … sometimes [radiologists] will see things that aren't clear, they have to follow it over time," he said. "AI improves how focused and how predictive it is, [shown] very dramatically in studies."
Siegel confirmed that radiologists across the country are generally in support of leveraging AI for cancer detection, especially in areas of the country that are "underserved" in terms of healthcare.
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"In areas where you're relying on radiologists without special training, this is even more important," he said.
"This is the wave of the future. AI is going to be part of the equation, but it's not going to take over."