FDA Approves First AI-Powered Breast Cancer Risk Prediction Tool

In a groundbreaking development for breast cancer screening and prevention, the Food and Drug Administration (FDA) has granted de novo authorization to Clairity, a Boston-based startup, for their artificial intelligence tool designed to predict a patient's five-year breast cancer risk from routine mammograms. This marks a significant shift in the application of AI in breast cancer detection and risk assessment.

Clairity Breast: A New Frontier in Cancer Risk Assessment

Clairity's innovative tool, named Clairity Breast, is the first of its kind to receive FDA approval. Unlike traditional computer-aided detection systems that focus on identifying existing cancers, Clairity Breast analyzes mammogram images to predict future breast cancer risk over a five-year period.

Dr. Connie Lehman, founder of Clairity and a diagnostic radiologist at Mass General Brigham, emphasized the tool's unique capabilities: "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. It's extracting subtle cues in the mammogram that the human eye can't see, the human brain can't process."

The company plans to launch the risk assessment feature by the end of the year, starting with select centers before expanding access.

Addressing Limitations in Current Risk Models

Current breast cancer risk models primarily consider factors such as age and family history. However, these models have limitations, as most people diagnosed with breast cancer have no family history of the disease. The World Health Organization reports that approximately 2.3 million new cases of breast cancer were diagnosed worldwide in 2022, highlighting the urgent need for more accurate risk prediction tools.

Clairity Breast aims to expand the identification of high-risk individuals who may have been overlooked by traditional risk assessment methods. The AI model was developed using Hologic's 2D screening mammography systems and will be integrated into routine mammogram procedures.

Diversity and Inclusivity in AI Development

Recognizing the historical bias in breast cancer risk prediction models, which were often built on data from predominantly white women, Clairity has made a concerted effort to train its AI models on a diverse group of patients. This approach aims to ensure more accurate and equitable risk assessments across different demographics.

As the pharmaceutical and medical technology industries continue to embrace AI-driven solutions, Clairity's FDA approval represents a significant milestone in the ongoing effort to improve breast cancer detection and prevention strategies.