About the Guest
Dr. Connie Lehman is the founder and CEO of Clairity, the company behind the first FDA-authorized AI platform that predicts a woman's five-year future risk of breast cancer. A physician scientist with over 300 peer-reviewed publications, Connie is a Professor of Radiology at Harvard Medical School and Breast Imaging Specialist at Massachusetts General Brigham (on leave). She holds an MD and PhD from Yale and was named to Forbes' 50 Over 50 Innovators and TIME 100 World’s Most Influential Leaders in Health.
Interview Summary
Connie’s training as a physician scientist, decades of research, and career as a radiologist formed the scientific foundation for Clairity, which she founded in December 2020.
The problem Connie kept seeing in her clinic was women falling through the cracks of screening. Existing clinical risk models identify, at best, 20% of women likely to develop breast cancer. Patients get missed because they're younger than the screening guidelines, or have no family history that flags them for elevated risk.
Clairity applies computer vision to the screening mammogram, extracting predictive signals that radiologists cannot see. The shift is conceptual as much as technical: instead of detecting existing disease, the Clairity Breast Risk Score predicts five-year risk in otherwise healthy women, opening the door to earlier screening and prevention.
Designed to fit existing care pathways, the product was validated on 75,000 mammograms across five centers for FDA submission, and has now been further validated in over 250,000 mammograms globally.
Clairity received FDA De Novo authorization in June 2025, was rapidly included in the 2026 NCCN national breast cancer screening guidelines, and closed a $43 million Series B in Q4 2025. The company initially launched at Beth Israel Deaconess Medical Center, with additional sites experimenting with scoring patients at the time of screening or running scores on prior mammograms. Self-pay is available while Clairity pursues a CPT code and payer coverage. A recent partnership with EverlyWell extends a direct-to-patient pathway for convenient access to Clairity’s technology.
Top Takeaways
Approach the physician-to-founder transition like a research grant. Physician-founders understand healthcare’s complexity, but academic training rarely covers FDA submissions, fundraising, or scaling. Start with clarity on the problem you’re solving. Then translate the same discipline that led to your strongest grants by assembling complementary expertise around a shared problem. Identify your gaps early and design your team around them from day one.
Creating a new category requires clinical rigor that can become your biggest moat. With no predicate, you can't borrow credibility; you have to earn it. Don’t be afraid to pursue a more challenging regulatory path, and let data define the product scope. If FDA struggles to understand your technology, bring in consultants who can help translate your science into something that’s easier to digest. Lean into clinical and regulatory rigor, because as it compounds, it turns into a standard that competitors must replicate.
Solve adoption through both clinical fit and patient access. On the clinical side, align with existing care pathways so you’re not asking physicians to change behavior or learn new workflows. For patients, build access creatively across multiple care settings, self-pay, and direct-to-consumer partnerships in order to reduce adoption friction. Patient behavior in healthcare is shifting; commercialization should meet them where they already are.
Sponsors
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