Key Highlights:
- First-of-Its-Kind FDA Clearance: Clairity Breast becomes the first AI tool approved to predict 5-year breast cancer risk using routine mammograms.
- AI Beyond Detection: Unlike traditional tools, Clairity analyzes subtle image patterns undetectable by humans to forecast future cancer risk.
- Equity-Focused Innovation: Trained on diverse datasets, Clairity’s model aims to close diagnostic gaps for women traditionally underrepresented in breast cancer prediction.
AI-Driven Risk Prediction: A Breakthrough in Preventive Oncology
Boston-based Clairity received FDA de novo authorization for Clairity Breast, an artificial intelligence tool that predicts a woman’s risk of developing breast cancer over a five-year period from a standard 2D mammogram. This approach moves beyond traditional detection models to a predictive, proactive framework that may revolutionize routine screenings.
Expanding Access to High-Risk Identification
Clairity Breast aims to identify women at high risk who may not show signs today or have family history—an area where current models fall short. According to founder Dr. Connie Lehman, the tool detects complex patterns invisible to the human eye, potentially expanding life-saving early intervention to a broader population.
Clinical and Commercial Roadmap
The company plans a phased rollout starting at select imaging centers before a broader launch later this year. With former Binx Health and Exact Sciences executive Jeffrey Luber as CEO, Clairity is poised to scale its predictive platform into standard clinical practice.
Commitment to Inclusive Healthcare Innovation
Clairity emphasized equity in its development process, training its AI models on racially and ethnically diverse patient data. This effort addresses historical biases in breast cancer risk prediction, ensuring the technology benefits all women, not just a select demographic.
About Clairity
Clairity is a Boston-based medical AI startup focused on redefining early detection and prevention in breast cancer care. The company develops innovative diagnostic tools using artificial intelligence and mammographic imaging to offer actionable risk prediction insights. Clairity is committed to equitable, accessible, and transformative healthcare innovation.
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