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6 days ago
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Clairity receives FDA OK for breast cancer risk prediction tool
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. The Food and Drug Administration has authorized the first artificial intelligence tool to predict patients' five-year breast cancer risk from a routine mammogram. Boston-based startup Clairity developed the tool, called Clairity Breast. The company plans to launch the risk assessment feature by the end of the year, according to a Monday announcement. 'We're doing something radically different than what I've done my whole career in the area of computer-aided detection and diagnosis of breast cancer,' Connie Lehman, founder of Clairity and a diagnostic radiologist at Mass General Brigham, said in an interview. AI has been used to detect breast cancer for decades; the first computer-aided detection system for breast cancer was approved in 1998, Lehman said. However, most of these tools are used to detect cancer, not predict future risk. 'What we're doing here is doing something humans can't do,' Lehman said. 'It's extracting subtle cues in the mammogram that the human eye can't see, the human brain can't process.' About 2.3 million new cases of breast cancer were diagnosed worldwide in 2022, according to the latest data from the World Health Organization. Current risk models factor in age and family history, but most people diagnosed have no family history. Lehman, who has focused most of her career on better ways to detect breast cancer early, expects the new approach will 'expand the net out to more women who truly are at high risk, and until now we haven't been able to identify.' Clairity Breast was developed using Hologic's 2D screening mammography systems. It would be used as part of a patient's routine mammogram. The company was careful to train its AI models on a diverse group of patients, Lehman said, as historically, breast cancer risk prediction models were built on data from predominantly white women. Clairity plans to launch the predictive tool starting with select centers and expanding access later this year, Lehman said. The company last year hired Jeffrey Luber as CEO to help lead the market launch. Luber is the former CEO of testing firms Binx Health and Exact Sciences. Clairity received a $1 million investment from the Breast Cancer Research Foundation in January. Recommended Reading Nvidia's David Niewolny on the future of AI in medical devices
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6 days ago
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FDA approves first AI tool to predict breast cancer risk
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. Ai Detects Ovarian Cancer Better Than Human Experts In New Study 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. Read On The Fox News App 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. Ai Detects Woman's Breast Cancer After Routine Screening Missed It: 'Deeply Grateful' 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." "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. Click Here To Sign Up For Our Health Newsletter 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. For more Health articles, visit "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."Original article source: FDA approves first AI tool to predict breast cancer risk
