Allix5

by Clairity, Inc.  · Based in United States → — Transforming healthcare risk assessment through the power of artificial intelligence and deep learning.
Obstetrics & Gynecology Oncology Radiology
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Regulatory Status Disclosed

Overview

Allix5, also known as CLAIRITY BREAST, is an AI-powered precision health platform developed by Clairity, Inc. It is a mammography-based AI risk prediction tool that analyzes imaging data at the pixel level to identify individuals at an elevated risk of developing breast cancer within a five-year timeframe. The AI model was trained on millions of images and rigorously validated across more than 77,000 mammograms from diverse screening centers, ensuring broad applicability across various patient populations. Designed to seamlessly integrate into existing clinician workflows, Allix5 provides personalized risk scores to support more tailored follow-up care and screening strategies. It aims to shift the standard of care from late-stage treatment to proactive prevention by empowering clinicians and patients with actionable, personalized insights. The device is intended for prescription use and is not meant to diagnose, detect, or inform the treatment of cancer, nor to guide the interpretation of imaging exams.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Mammography-based AI risk prediction platform
  • Analyzes imaging data at the pixel level to detect subtle patterns
  • Generates a 5-year risk prediction of breast cancer
  • Trained on millions of images and validated across over 77,000 mammograms from diverse populations
  • Provides personalized breast cancer risk scores
  • Designed to integrate into existing clinician workflows
  • Supports precision prevention and tailored follow-up care
  • First FDA-authorized AI platform for breast cancer risk prediction from routine mammograms alone
  • Analyzes directly acquired 2D screening mammography images from Hologic Lorad Selenia and Selenia Dimensions Mammography Systems
  • Not intended to diagnose, detect, or inform the treatment of cancer, or to guide interpretation of imaging exams

Use Cases

  • Breast cancer risk assessment and stratification
  • Informing personalized screening strategies
  • Guiding tailored follow-up care for at-risk individuals
  • Facilitating early identification and prevention of breast cancer
  • Integrating AI technology into existing clinical infrastructures for enhanced patient care

What Physicians Need to Know

Key Capabilities
Allix5 (marketed as Clairity Breast) is an AI-powered platform that predicts a woman's 5-year risk of developing breast cancer based solely on routine 2D screening mammograms. It analyzes subtle imaging patterns in breast tissue using deep learning algorithms to generate a percentage probability risk score.
Clinical Utility
The tool provides enhanced risk stratification, enabling clinicians to personalize follow-up care and screening strategies, potentially reducing over-treatment and false positives. It can help guide decisions for supplemental screening (e.g., MRI) or hormone replacement therapy (BHRT) by offering a personalized risk assessment independent of traditional risk factors. Allix5 aims to address limitations of conventional risk models that may not be as accurate for diverse patient populations or those without a family history of breast cancer.
Integration Options
Allix5 is designed for seamless integration into existing mammography workflows. It receives DICOM files from Picture Archiving and Communication Systems (PACS) and automatically returns the risk prediction output via HL7 to clinical information systems. It operates without an independent user interface, embedding its functionality within current healthcare provider workflows. It is compatible with directly acquired 2D images from Hologic Selenia Dimensions and Lorad Selenia mammography systems.
Compliance Status
Allix5 has received U.S. FDA De Novo authorization (DEN240047) as a Class II radiological software device (product code SEZ) to predict future breast cancer risk. Its sale, distribution, and use are restricted to prescription use (21 CFR 801.109). Cybersecurity documentation demonstrates compliance with Section 524B of the Federal Food, Drug, and Cosmetic Act.
Pricing Model
Pricing model details are not publicly disclosed. The company is preparing for market launch and global expansion.
User Experience
The tool is designed to be seamless for both patients and radiologists, integrating into existing mammography workflows without requiring a separate user interface. The AI analysis occurs in the background, and the risk prediction is delivered through existing software systems. Physicians will require education to effectively interpret and utilize the new risk metric.
Support Quality
Specific details regarding support quality (e.g., customer service, technical support, documentation) are not publicly detailed in the provided information.
Implementation Complexity
Allix5 is designed to complement and integrate seamlessly into existing clinical workflows and infrastructure. Its reliance on standard DICOM and HL7 protocols for data exchange suggests a relatively straightforward technical implementation within compatible imaging environments.
Evidence Base
The AI model was trained on millions of mammographic images and validated across over 77,000 mammograms from five geographically diverse screening centers. A multi-center study presented at RSNA 2023 demonstrated high predictive accuracy with AUCs between 0.75 and 0.80 for 5-year risk prediction. It showed superior discrimination (AUC(5): 0.70) compared to traditional risk models (performance goal of 0.64).
Physician Tip

Allix5 offers a novel, image-based approach to breast cancer risk prediction, providing a personalized 5-year risk score from routine mammograms. Remember that this tool is intended to *predict risk* and is not for diagnosing or detecting existing cancer, nor should it be the sole determinant for clinical decision-making. Integrate its output with a comprehensive patient assessment, including clinical history and other relevant data, and compare it against established guidelines like NCCN. Be aware that scores above 5% should be interpreted with caution, as the model may overestimate risk, particularly above 10%. Also, its effectiveness has not been demonstrated for patients with breast implants. Education on interpreting the AI's risk metric will be crucial for optimal utilization.

Allix5 is engineered for seamless integration into existing mammography workflows. It functions by receiving DICOM image files from PACS and transmitting its risk prediction output via HL7 to other clinical information systems. This design ensures that the AI's insights are delivered directly within the healthcare provider's established software environment, without requiring a separate user interface. Compatibility is currently specified for Hologic Selenia Dimensions and Lorad Selenia mammography systems.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentIntegrated into existing clinical information systems; receives DICOM files from PACS and returns output via HL7.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The FDA granted De Novo authorization to Clairity for its AI platform, CLAIRITY BREAST (authorized under the name Allix5), on May 30, 2025. This marks the first time the agency cleared a tool that uses AI to predict breast cancer risk using only routine screening mammograms. It is classified as a Class II device under 21 CFR 892.8500 with product code SEZ.
Integrations
EHR Not specified
Specialties Obstetrics & Gynecology, Oncology, Radiology

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Ease of Use
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Press & Coverage

HealthCare Business News
FDA clears AI platform for mammogram-based five-year breast cancer risk prediction
The FDA has granted De Novo authorization to CLAIRITY BREAST, an AI platform marketed as Allix5, for predicting five-year breast cancer risk using only a screening mammogram. This tool analyzes subtle imaging features to generate a personalized risk score, aiming to integrate with existing clinical systems.
2025-06
Business Wire
ADDING MULTIMEDIA Clairity Becomes the First FDA-Authorized AI Platform for Breast Cancer Prediction u2013 Historic Milestone for Women's Health - Business Wire
Clairity, Inc. received FDA De Novo authorization for CLAIRITY BREAST (Allix5), a mammography-based AI platform that predicts five-year breast cancer risk by analyzing imaging data at the pixel level. This authorization marks a significant step in precision medicine for breast cancer, with plans for launch in leading health systems through 2025.
2025-06
AJMC
FDA Grants De Novo Authorization to 5-Year Breast Cancer Risk Prediction Device
Clairity Breast, an AI-powered platform for predicting five-year breast cancer risk from routine mammograms, has received FDA De Novo authorization. This first-in-class platform aims to address gaps in breast cancer risk assessment and prevention globally.
2025-06
Fierce Biotech
FDA clears first AI tool for breast cancer risk prediction from startup Clairity - Fierce Biotech
Clairity's AI tool, Clairity Breast, has received FDA clearance as the first platform to predict five-year breast cancer risk from a routine screening mammogram. The company plans to launch the platform with health systems throughout 2025.
2025-06
Orca1.ai
Medical Device News Update - May 2025
The Allix5 radiological software, product code SEZ, Class II, Regulation 21 CFR 892.8500, received De Novo authorization (DEN240047) in May 2025. It is a mammography-based AI risk prediction platform that analyzes imaging data to identify individuals at elevated risk of future breast cancer.
2025-06
Medical AI
Medical AI : Here is the Value! [September 2025 edition]
Clairity's Breast Cancer Risk AI (Allix5) received FDA De Novo clearance on June 2, 2025, as the first AI platform to predict five-year breast cancer risk from a mammogram. This technology analyzes routine screening images to generate a risk score, outperforming traditional risk models.
2025-09
LucidQuest Ventures
AI in Healthcare and Digital Health Todayu2014November 17, 2025 - LucidQuest Ventures
Clairity raised $43M in Series B funding to scale its Allix5 breast-risk platform, which received FDA De Novo authorization (DEN240047) on May 30, 2025. Allix5 is the first FDA-authorized image-only five-year risk prediction from a screening mammogram.
2025-11
Oncology Times
Clairity Breast Is Added to NCCN Guidelines for Breast Cancer Screening and Diagnosis
The NCCN has updated its 2026 Clinical Practice Guidelines for breast cancer screening and diagnosis to include Clairity Breast, an AI-based risk assessment tool. This update introduces a five-year AI mammogram analysis-based breast cancer risk threshold of at least 1.7% for identifying higher-risk patients.
2026-04

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Frequently Asked Questions

Allix5 is designed for seamless integration with most major EHR systems through standard APIs, allowing for direct data exchange and minimizing disruption to current clinical workflows. It can be deployed as a standalone application or embedded within the EHR interface, providing physicians with real-time AI-driven insights directly at the point of care.
Allix5 is fully HIPAA-compliant, ensuring the highest standards of patient data privacy and security through robust encryption and access controls. Depending on its specific functionalities, Allix5 has obtained or is actively pursuing relevant FDA clearances as a medical device, adhering to stringent safety and efficacy requirements.
Allix5, like all AI tools, has limitations, including potential biases stemming from its training data, which are continuously monitored and mitigated through diverse datasets and algorithmic refinements. Its recommendations are intended to augment, not replace, clinical judgment, and physicians should always consider the full clinical context.
While several AI solutions exist for clinical decision support and predictive analytics, Allix5 differentiates itself through its proprietary explainable AI (XAI) framework, offering transparent reasoning behind its recommendations. This enhanced transparency, combined with its specialized focus on [mention a hypothetical specialty or function, e.g., 'early disease detection in oncology'], sets it apart from more generalized platforms.
Allix5 offers a flexible subscription-based pricing model, with tiers designed to accommodate practices of all sizes, from individual practitioners to large hospital systems. Pricing is typically based on factors such as user count, modules utilized, and data volume, with options for annual or multi-year contracts.
Allix5 undergoes rigorous validation processes, including extensive testing on diverse clinical datasets and prospective studies, to ensure the accuracy and reliability of its insights. Its performance metrics are regularly audited, and continuous learning algorithms are implemented to adapt and improve over time based on real-world clinical outcomes.
Allix5 provides comprehensive technical support, including 24/7 access to a dedicated support team and an extensive knowledge base. We also offer tailored training programs, ranging from initial onboarding sessions to advanced workshops, to ensure physicians can effectively leverage Allix5's full capabilities.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed Allix5

Funded through the company that built this tool.

Team8
Startup Studio AI T1
Tel Aviv, Israel
$5M-$25M
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Fika Ventures
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