The U.S. Food and Drug Administration (FDA) has authorized the first-ever artificial intelligence (AI) tool designed to predict a woman’s five-year risk of breast cancer using a routine screening mammogram. The announcement, made on May 30, 2025by the tool’s developer, Clairity, marks a pivotal step in how breast cancer is detected and prevented—and it may just redefine the standard of care in women’s health.This isn’t just another AI detection tool. Clairity’s platform, known as CLAIRITY BREAST, is not focused on spotting existing tumors, but rather on forecasting who may develop breast cancer years in advance. It shifts the paradigm from early detection to early risk prediction, potentially giving clinicians a critical head start in identifying high-risk individuals—before cancer ever forms.This innovation comes from the vision of Dr. Connie Lehman, a radiologist and professor at Harvard Medical School, and the former chief of breast imaging at Massachusetts General Hospital. With decades of experience detecting cancers on mammograms, Lehman realized a key gap in screening: the lack of modern, image-based risk assessment tools.“Our imaging technology was advancing fast, but our methods to identify women at high risk weren’t keeping up,” said Lehman at the 2025 American Society of Clinical Oncology (ASCO) Meeting, where the FDA authorization was announced.While most existing risk models consider age, genetics, and family history, they often miss women who don’t fit those boxes. In fact, 85% of women diagnosed with breast cancer have no family history, and 50% have no identifiable risk factors at all. This makes Clairity’s approach uniquely valuable.How The Breast Cancer Detection AI Tool Works?CLAIRITY BREAST leverages deep learning and computer vision algorithms trained on millions of mammogram images, each linked to five-year follow-up data. By analyzing the subtle imaging features in breast tissue—often imperceptible to the human eye—the system generates a validated five-year risk score for each patient.That score is integrated seamlessly into existing clinical workflows, providing radiologists and oncologists with a powerful new layer of information for decision-making.“Now we can move even further upstream,” said Lehman. “Not just detecting cancer early—but predicting it, personalizing care, and even preventing it.”Traditional screening strategies are reactive, catching cancer once it’s already present. But with Clairity, the approach becomes proactive, especially for women who may otherwise fall through the cracks of conventional risk models.“This FDA authorization is a turning point,” said Dr. Larry Norton, founding scientific director at the Breast Cancer Research Foundation. “Most existing risk models miss the very women who go on to develop breast cancer. Clairity changes that.”Younger women in particular stand to benefit. While breast cancer incidence is still highest in women over 50, cases among younger women are rising, yet they’re often not recommended for routine screening unless they have known risk factors. Clairity’s AI-powered insights can help clinicians tailor screening plans and intervene earlier for women who previously would have gone unflagged.Dr. Lehman describes breast cancer not as a binary—either present or not—but as a continuum, with progression that begins long before a tumor is visible.“There’s a point even before ductal carcinoma in situ (DCIS), when cancer hasn’t developed, but the risk is there,” she explained. “That’s where CLAIRITY can intervene—well before invasive cancer begins.”The goal, according to Lehman, isn’t just to detect breast cancer earlier, but to predict and prevent it, in the same way that doctors routinely assess cardiovascular risk based on blood pressure, cholesterol, or BMI.Until now, breast cancer lacked such a dynamic, image-based risk tool. That’s what makes Clairity’s authorization so significant.AI’s Expanding Role in RadiologyAI has been used in radiology for decades, first to flag microcalcifications in mammograms in the early '90s. But back then, AI systems were limited to rule-based logic and needed exhaustive human guidance.Today’s AI, especially in platforms like Clairity, goes far beyond what human vision can perceive. It identifies patterns in breast tissue texture and density at the pixel level, learning from vast image sets without needing explicit human-labeled inputs.Lehman compared it to how machines learn to distinguish cats from dogs—by exposure to thousands of examples rather than being told what features to look for. In the case of breast cancer, the stakes are obviously much higher.“This technology allows us to see what we couldn’t see before, and that opens doors to dynamic risk assessment,” Lehman said. “Eventually, we may even use these tools to monitor how interventions like medication, weight loss, or hormone therapy change a woman’s risk over time.”Backed by Santé Ventures and ACE Global Venture, Clairity was founded in 2020 with a clear goal: to bring sophisticated AI tools to routine mammography. Now, with FDA de novo authorization, it’s set to hit the market by late 2025.The company estimates the global market for breast cancer prediction tools at $63 billion, suggesting broad clinical interest and commercial potential.As imaging centers, hospitals, and oncologists look to integrate risk prediction into daily care, Clairity's success will depend on adoption, clinician trust, and real-world outcomes. But with this regulatory milestone, a major hurdle has been cleared.The FDA’s green light for CLAIRITY BREAST doesn’t just add a new tool to the cancer detection toolbox—it fundamentally changes the playing field. By enabling risk prediction from a single mammogram, it turns routine screening into a forward-looking, personalized roadmap for prevention.