About
Clairity Breast is a groundbreaking, FDA-authorized AI-powered clinical platform that transforms routine breast cancer screening by predicting a woman's five-year risk of developing breast cancer — using only her existing screening mammogram, with no additional testing required. Developed with deep expertise in medical imaging AI and computer vision, the platform identifies subtle, invisible patterns in mammogram images that are undetectable to the human eye, enabling a proactive, risk-stratified approach to breast health. The platform delivers validated, equitable risk assessments, making it suitable for diverse patient populations and addressing longstanding disparities in cancer risk identification. Endorsed by new NCCN (National Comprehensive Cancer Network) guidelines, Clairity Breast supports risk assessments beginning at age 35 — earlier than many traditional screening thresholds — helping clinicians identify increased-risk women who would otherwise be missed by conventional methods. Clairity Breast is designed for integration within health systems, empowering radiologists, oncologists, and primary care providers with actionable risk intelligence directly from the mammography workflow. It targets a major paradigm shift in breast cancer care: moving from reactive detection to proactive, personalized risk management. The platform is actively launching at health systems across the United States, with a waitlist available for patients and providers at new locations. It is best suited for healthcare institutions, radiology departments, and women's health programs looking to modernize their breast cancer screening protocols with clinically validated AI.
Key Features
- FDA-Authorized Risk Prediction: The first and only FDA-authorized AI platform cleared to predict a woman's five-year future risk of breast cancer from a standard screening mammogram.
- No Additional Testing Required: Clairity Breast works entirely from existing screening mammogram images, seamlessly integrating into current workflows without requiring new tests or procedures.
- Advanced Computer Vision Analysis: Uses AI and computer vision to detect subtle mammographic patterns invisible to the human eye, uncovering hidden risk signals in imaging data.
- Equitable Risk Assessment: Validated across diverse patient populations to deliver equitable, reliable risk scores, helping reduce disparities in breast cancer early detection.
- NCCN Guideline Aligned: Endorsed by new NCCN guidelines, supporting AI-based risk assessment starting at age 35 to identify at-risk women missed by traditional screening methods.
Use Cases
- Breast cancer risk stratification during routine mammography screening at health systems and radiology centers.
- Early identification of high-risk women starting at age 35, enabling proactive supplemental screening or preventive interventions.
- Supporting radiologists and oncologists with AI-driven risk intelligence to guide clinical decision-making and personalized care plans.
- Expanding equitable access to breast cancer risk assessment in underserved or diverse patient populations where traditional risk models underperform.
- Health system-level population health management programs focused on reducing late-stage breast cancer diagnoses through earlier, risk-based detection.
Pros
- First FDA-Authorized Platform of Its Kind: Clairity Breast holds a unique regulatory position as the first FDA-authorized AI tool for mammogram-based five-year breast cancer risk prediction, providing clinical credibility and trust.
- Seamless Integration Into Existing Workflows: Leverages mammograms already being taken, meaning no change in patient experience or additional imaging is required for risk stratification.
- Earlier Risk Identification: Supports risk assessment beginning at age 35, enabling proactive intervention for women who would otherwise be missed until later in traditional screening programs.
- Clinically Validated and Equitable: Backed by rigorous validation studies and designed to perform equitably across diverse demographics, increasing reliability for health systems serving varied populations.
Cons
- Limited Availability During Launch Phase: Currently launching at select health systems across the USA, meaning many patients and providers cannot yet access the platform without joining a waitlist.
- Requires Health System Partnership: Patients cannot access Clairity Breast directly — it must be offered through a participating health system or radiology provider, limiting individual access.
- Scope Limited to Breast Cancer Risk: The platform focuses exclusively on breast cancer risk prediction from mammograms and does not extend to other cancer types or general health risk assessments.
Frequently Asked Questions
What is Clairity Breast?
Clairity Breast is the first FDA-authorized AI platform designed to predict a woman's five-year future risk of developing breast cancer, using only her existing screening mammogram — no additional tests required.
How does Clairity Breast work?
The platform uses advanced AI and computer vision algorithms to analyze standard mammogram images, detecting subtle patterns that are invisible to the human eye. These patterns are used to generate a validated five-year breast cancer risk score for each patient.
Is Clairity Breast FDA authorized?
Yes, Clairity Breast is FDA-authorized, making it the first AI platform of its kind to receive this clearance for predicting future breast cancer risk from screening mammograms.
Who can access Clairity Breast?
Clairity Breast is designed for health systems, hospitals, and radiology practices. Patients can access it through participating health systems. A waitlist is available for those whose local health system has not yet launched the platform.
How does Clairity Breast differ from traditional mammogram screening?
Traditional mammograms detect existing cancers. Clairity Breast goes a step further by analyzing the same image to predict the likelihood of developing breast cancer over the next five years, enabling earlier preventive action and risk-stratified care.
