BOSTON & CHICAGO--(BUSINESS WIRE)--Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S. Food and Drug Administration (FDA) De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025 – propelling a new era of precision medicine in breast cancer.

Each year, more than 2.3 million new cases of breast cancer are diagnosed worldwide¹, including over 370,000 cases in women in the United States². Early detection and risk reduction are powerful tools to save lives, but their most effective deployment depends on accurate risk assessment. Most risk assessment models rely heavily on age and family history to predict risk. However, 85% of women diagnosed with breast cancer have no family history, and nearly half have no identifiable risk factors^3,4. In addition, traditional risk models, built on data from predominantly European Caucasian women, have not generalized well to women of diverse racial and ethnic backgrounds⁵.

CLAIRITY BREAST analyzes subtle imaging features on screening mammograms that correlate with future breast cancer risk, making early risk prediction feasible based on a screening mammogram alone. The result is a validated five-year risk score delivered to healthcare providers through existing clinical infrastructures, supporting more personalized follow up care.

“For more than 60 years, mammograms have saved lives by detecting early-stage cancers. Now, advancements in AI and computer vision can uncover hidden clues in the mammograms – invisible to the human eye – to help predict future risk,” said Dr. Connie Lehman, Founder of Clairity, who is also a breast imaging specialist at Mass General Brigham. “By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere.”

“Personalized, risk-based screening is critical to improving breast cancer outcomes, and AI tools offer us the best opportunity to fulfill that potential,” said Dr. Robert A. Smith, Senior Vice President of Early Cancer Detection Science at the American Cancer Society. “By integrating AI models that assess individual risk, we can better identify women at higher risk, and those who may benefit from supplemental screening methods, such as MRI, improving early detection and more effective prevention strategies.”

“Clairity’s FDA authorization is a turning point for more women to access the scientific advances of AI-driven cancer risk prediction,” said Larry Norton, Founding Scientific Director of the Breast Cancer Research Foundation. “Breast cancer is rising, especially among younger women, yet most risk models often miss those who will develop the disease. Now we can ensure more women get the right care at the right time.”

“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,” said Jeff Luber, CEO of Clairity. “CLAIRITY BREAST is designed to fit seamlessly into the current clinical infrastructure to help providers scale precision prevention – with the goal of reducing late-stage diagnoses, lowering costs, and saving more lives.”

The FDA De Novo authorization positions CLAIRITY BREAST as a first-in-class platform within the $63 billion global breast cancer prediction market, ushering in a new standard for personalized, risk-based screening and cancer prevention.

Be the first to know when it launches, and how you can get it: https://clairity.com/first-to-know/

About CLAIRITY BREAST

CLAIRITY BREAST, authorized under the name Allix5, is a mammography-based AI risk prediction platform that analyzes imaging data at the pixel level to identify individuals at elevated risk of future breast cancer. The AI model behind CLAIRITY BREAST was trained on millions of images and validated across more than 77,000 mammograms from five geographically distinct screening centers – including hospital-based and free-standing facilities – that collectively serve a diverse patient population, with validation anchored in five-year outcome data. To learn more about indications for use, visit: https://clairity.com/clairity-breast/

Clairity’s first-in-class platform was designed to complement existing clinician workflows, making it uniquely positioned to address, at scale, the widespread shortfalls in breast cancer risk assessment and cancer prevention.

About Clairity

Founded in 2020 and headquartered in Boston, Massachusetts, Clairity, Inc. is transforming healthcare risk assessment through the power of artificial intelligence and deep learning. Founded by Dr. Connie Lehman, backed by Santé Ventures and ACE Global Equity, Clairity's technology can uncover subtle patterns in routine images that are invisible to the human eye, enhancing risk prediction to empower clinicians and their patients with actionable, personalized insights. Clairity’s mission is to shift the standard of care from late-stage treatment to proactive prevention. To learn more, visit us at www.clairity.com | LinkedIn

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References:

¹ https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834

² https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf

³ https://www.who.int/news-room/fact-sheets/detail/breast-cancer

⁴ https://www.breastcancer.org/facts-statistics

⁵ https://www.nejm.org/doi/full/10.1056/NEJMms2004740

Contacts

Media Contact:
Nina Gill
LaVoieHealthScience
781-856-3103
ngill@lavoiehealthscience.com

Investor Interest:
Sam Libby
TCB Capital Advisors
973-563-3141
samlibby@tcbcapitaladvisors.com

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