In a significant move, the U.S. Food and Drug Administration (FDA) has provided De Novo authorisation Clairity Breast, the novel, image-based prognostic artificial intelligence (AI) platform that accurately predicts a woman’s risk for breast cancer.
Clairity Breast is particularly developed to assess prognosis and predict the five-year risk for developing breast cancer.
It assesses subtle imaging features on routine mammograms and delivers a validated five-year risk score to medical professionals through their current clinical systems.
Jeff Luber, chief executive officer of Clairity stated, "What makes the availability of Clairity Breast a true sea change is that we're now predicting risk of future cancer from patterns in breast tissue, in an otherwise normal screening, before it's even there."
Clairity Breast — A cutting-edge AI tool
Clairity Breast’s AI model has received training using millions of photos.
In addition, its performance has been validated across a dataset of nearly 77,000 mammograms from reputable screening centres.
Robert A. Smith, M.D., senior vice president of early cancer detection science at the American Cancer Society highlighted the significance of risk-based screening for enhanced breast cancer outcomes.
Experts further stated that incorporating AI models may help analyse women's risk of developing a life-threatening disease.
It may benefit from supplemental screening methods, including enhancing early detection and more efficient prevention strategies.
