Clairity Secures $43M Series B to Commercialize First FDA-Authorized AI Platform for Breast Cancer Risk Prediction
核心洞察
Clairity (搜索) raised $43 million in Series B funding led by ACE Global Equity (搜索) and Santé Ventures (搜索) to commercialize its FDA-authorized AI platform that predicts five-year breast cancer risk from routine mammograms.
The Clairity Breast (搜索) platform represents the first FDA-cleared artificial intelligence tool capable of estimating a woman's five-year breast cancer risk directly from standard 2D mammogram images.
The funding will accelerate U.S. commercialization, expand partnerships with imaging centers and health systems, and support development of additional AI-based predictive tools for cardiovascular disease.
Clairity (搜索) has secured $43 million in Series B financing to commercialize its groundbreaking artificial intelligence platform that predicts breast cancer risk from routine mammograms. The funding round, led by ACE Global Equity (搜索) and Santé Ventures (搜索), will accelerate the rollout of Clairity Breast (搜索), the first FDA-authorized AI tool capable of estimating a woman's five-year breast cancer risk directly from standard imaging.
The Breast Cancer Research Foundation (搜索) (BCRF) continued its participation in the funding round, alongside several new investors. Joe Kiani, Founder and Executive Chairman of Willow Laboratories and Founder of Masimo (NASDAQ: MASI), joined as both investor and board member.
Revolutionary Approach to Breast Cancer Risk Assessment
Clairity Breast (搜索) uses artificial intelligence to analyze 2D mammogram images, trained on mammogram images matched with five-year outcome data. The AI model identifies patterns in breast tissue that correlate with future cancer development, enabling healthcare providers to predict risk before cancer becomes visible.
"For decades, we have relied on mammography to detect cancer only after it is visible," said Connie Lehman, MD, PhD, Founder of Clairity (搜索). "With Clairity Breast (搜索), we can now use the same images to predict who may be at risk over the next five years, supporting earlier intervention, fewer late-stage diagnoses, and more lives saved. This is the future of breast cancer care: predictive, personalized, and preventive."
The platform received FDA de novo authorization in June, clearing the regulatory pathway for commercial deployment. Following initial rollout to marquee health systems, Clairity (搜索) is now expanding its reach across the healthcare landscape.
Commercial Expansion and Strategic Partnerships
The Series B funding will support multiple strategic initiatives, including accelerated U.S. commercialization and expanded partnerships with leading imaging centers and health systems. The company has initially targeted marquee health systems and is now ready to broaden the rollout to community imaging centers nationwide.
"Our fundraising is about more than capital; it's about momentum," said Jeff Luber, Clairity (搜索)'s President and CEO. "With FDA authorization in hand and commercial partnerships underway, Clairity Breast (搜索) is poised to redefine how the world approaches breast cancer. We're proud to stand at the forefront of a paradigm shift—from detection to prevention—and to deliver technology that empowers women and their doctors to predict risk to support action before cancer starts."
The funding will also support reimbursement initiatives aimed at making Clairity Breast (搜索) accessible across community imaging centers nationwide, addressing a critical need for broader access to predictive breast cancer screening.
Platform Expansion Beyond Breast Cancer
Clairity (搜索) is leveraging its deep learning framework to develop additional AI-based predictive offerings for other major diseases. The company's pipeline includes Clairity Breast (搜索) 3D and Clairity Heart, which will predict cardiovascular risk from the same routine imaging exam used for breast cancer screening.
"Clairity (搜索) represents a rare combination of scientific rigor, regulatory validation, and transformative clinical impact," said Gabriella Antici, Partner and Chief Investment Officer, ACE Global Equity (搜索). "Predictive imaging is the next frontier in oncology, and Clairity Breast (搜索) is the first real-world embodiment of that promise."
Industry Impact and Future Vision
The investment reflects growing confidence in AI-driven predictive healthcare solutions that can transform existing medical infrastructure into proactive tools for disease prevention. By utilizing routine mammography equipment already in place across healthcare systems, Clairity (搜索)'s approach offers a scalable solution for population health management.
"BCRF has long believed that prevention is the ultimate cure," said Donna McKay, President and CEO, Breast Cancer Research Foundation (搜索). "Clairity (搜索)'s technology embodies that vision, turning existing imaging infrastructure into a proactive tool for risk stratification toward earlier interventions that can save lives."
Kevin Lalande, Founding Managing Director and Chief Investment Officer of Santé Ventures (搜索), emphasized the platform's potential for healthcare system efficiency: "By pairing clinically validated AI with scalable access channels, Clairity (搜索) exemplifies the type of innovation that can help drive better outcomes for patients and greater cost efficiency across the healthcare system."
TCB Capital Advisors (搜索) served as exclusive financial advisor to Clairity (搜索) for the Series B financing round.