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Clairity

Category: AI in Healthcare

FDA-authorized AI platform that predicts a woman's 5-year risk of developing breast cancer using only routine screening mammogram images, without requiring demographic data or family history. Clairity was founded in 2020. The company is led by Dr. Connie Lehman. Based in Boston, United States. Team size: 10-50. Total funding raised: $46.8M. Latest round: Series B. Key investors include ACE Global Equity, Santé Ventures, Breast Cancer Research Foundation.

Founded
2020
Headquarters
Boston, United States
Team size
10-50
Total funding
$46.8M

Value proposition

Transforms breast cancer screening from reactive detection to proactive prevention by identifying women at elevated risk before cancer develops, enabling earlier intervention, personalized screening strategies, and improved outcomes for the 85% of women diagnosed who have no family history and nearly half with no identifiable risk factors.

Products and solutions

Clairity Breast (FDA-authorized 5-year risk prediction from 2D mammograms), Clairity Breast 3D (in development - for 3D mammography/tomosynthesis), Clairity Heart (in development - cardiovascular risk prediction from same imaging exams)

Unique value

First and only FDA De Novo-authorized AI platform that predicts future breast cancer risk exclusively from mammogram images at the pixel level, detecting subtle imaging patterns correlated with long-term risk that are invisible to the human eye. Unlike traditional risk models (Gail, Tyrer-Cuzick) that rely on age, family history, and genetics, Clairity requires only the screening image itself—addressing the critical gap that 85% of women diagnosed have no family history and nearly half have no identifiable risk factors.

Target customer

Health systems, breast imaging centers, radiology practices, academic medical centers, and hospitals performing routine mammography screening

Industries served

Healthcare AI, Medical Technology, Digital Health, Oncology, Radiology, Women's Health, Precision Medicine

Technology advantage

Proprietary deep learning model (Allix5) trained on millions of mammogram images matched with five-year outcome data from a multi-center international consortium. The AI analyzes full-field digital mammograms at pixel-level granularity to identify imaging features predictive of future cancer development. Designed to integrate seamlessly into existing clinical workflows, delivering validated 5-year risk scores through standard radiology systems without additional imaging or patient procedures.

How they differentiate

First and only FDA De Novo-authorized AI platform (DEN240047) that predicts 5-year breast cancer risk exclusively from routine mammogram images without requiring demographic data, family history, or genetic information. Clairity's image-only approach addresses the critical gap that 85% of women diagnosed with breast cancer have no family history and nearly half have no identifiable risk factors.

Main competitors

iCAD, DeepHealth (Kheiron Medical Technologies), Whiterabbit.ai

Key partnerships

Beth Israel Deaconess Medical Center (first clinical deployment partner, February 2026), MagView (integration with Luminary Risk platform for comprehensive risk assessment; partnership highlighted at SBI 2026, April 2026), Santé Ventures (lead investor), ACE Global Equity (co-lead investor in $43M Series B), Breast Cancer Research Foundation (research collaboration and validation support)

Notable customers

Beth Israel Deaconess Medical Center

Major milestones

FDA De Novo authorization for Allix5 (May 30, 2025), Series B funding: $43M raised (November 2025), First clinical deployment at Beth Israel Deaconess Medical Center (February 2026), Dr. Connie Lehman named to TIME's 2026 TIME100 Health List, Featured on NBC's TODAY Show (October 2025), Validation across 77,000+ mammograms from 5 geographically distinct screening centers, NCCN Guidelines updated to include AI mammogram-based risk assessment (April 14, 2026)

Growth metrics

First clinical deployment achieved at Beth Israel Deaconess Medical Center (February 2026); NCCN Guidelines updated to include AI mammogram-based risk assessment (April 2026); commercial rollout underway across U.S. health systems following FDA authorization

Market positioning

Pioneer and category creator in predictive breast health AI, positioned at the forefront of transforming breast cancer screening from reactive detection to proactive prevention. Holds first-mover advantage with the only FDA-authorized 5-year risk prediction tool for breast cancer.

Geographic focus

United States (initial commercial launch); planning expansion to Europe and Canada; Boston headquarters with deployment beginning at major U.S. health systems

Patents and IP

FDA De Novo authorization for Allix5 (DEN240047) granted May 30, 2025—De Novo is a rare regulatory pathway (less than 1% of FDA authorizations) reserved for novel devices with no existing predicate.

About Dr. Connie Lehman

Dr. Connie Lehman is a Professor of Radiology at Harvard Medical School and Breast Imaging Specialist at Massachusetts General Hospital (currently on leave). She has authored over 300 peer-reviewed scientific publications spanning computer-aided diagnosis, deep learning, artificial intelligence, density assessment, predictive risk modeling, and advancements in breast cancer screening and diagnosis. She was named to Forbes' 50 Over 50 Innovators list (2025) and TIME's 2026 TIME100 Health list.

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