Aidoc Secures FDA Clearance for Healthcare's First Comprehensive Foundation Model AI

11 newly cleared indications, combined with three existing ones, introduce an AI safety net for crowded Emergency Departments and imaging backlogs

NEW YORK, Jan. 21, 2026 /PRNewswire/ -- Aidoc, the pioneer and global leader of clinical AI, today announced that the U.S. Food and Drug Administration (FDA) has cleared the healthcare industry's first comprehensive AI triage solution^[1],[2], enabling health systems to surface critical findings earlier and reduce delays in patient flow amid Emergency Department (ED) crowding and imaging backlogs. This breakthrough was made possible by CARE™, Aidoc's self-developed AI foundation model. The solution brings 11 newly cleared indications and three previously cleared indications together into a single workflow, enabling triage of a wide range of acute findings during high clinical demand.

EDs face sustained pressure as patient volumes rise and imaging backlogs grow, contributing to delays and crowding. With ED imaging typically read first-in, first-out, Aidoc's shift to comprehensive triage of abdomen CT provides a safety net that surfaces acute findings earlier, supporting timely clinical decision-making and improving patient flow.

The same safety net extends to ambulatory settings, where unexpected critical findings can emerge from routine exams sitting in lengthy backlogs. By flagging these cases earlier, the solution helps reduce patient safety risk and supports timely follow-up.

This clearance validates Aidoc's foundation-model approach to delivering comprehensive clinical AI at scale. It represents the first FDA clearance of a comprehensive set of double-digit acute indications powered by a single foundation model. The solution delivers markedly improved signal quality, with roughly an order-of-magnitude reduction in false alerts compared to best-in-class, single-condition solutions. In the FDA-reviewed pivotal study, the 11 indications achieved a mean sensitivity of 97% (up to 98.5%) and a mean specificity of 98% (up to 99.7%), enabling the safety, quality, and reliability required for real-world adoption.^[1]

"The ability to bring key acute conditions together into a single workflow is a fundamental shift in how radiology departments operate," said Heidi Beilis, MD, FACR, Chief Medical Officer of Diagnostics at WellSpan Health. "We've integrated numerous AI tools across our imaging operations, but this comprehensive triage solution can directly address core challenges in the field, including how we manage workflow, accelerating time-to-diagnosis for acute conditions and, ultimately, improving patient outcomes."

The comprehensive abdomen CT triage solution is delivered through Aidoc aiOS™, the company's enterprise AI operating system. aiOS sustains AI performance and impact at foundation-model scale through data normalization, continuous performance monitoring, and built-in governance, enabling health systems to deploy and manage multi-condition clinical AI without re-architecting infrastructure. With more than 100 million patient cases analyzed, aiOS is the most widely deployed clinical AI platform in healthcare.

"Health systems are increasingly looking to AI to improve access and tackle their most pressing priorities," said Elad Walach, CEO and co-founder of Aidoc. "With CARE, we knew breadth alone wasn't enough. We were committed to meeting the safety and quality threshold required for real-world clinical use. This FDA clearance, combining unprecedented breadth and accuracy, marks a new era for clinical AI, and we're excited to partner with physicians to improve patient care worldwide."

The CARE solution roadmap is expected to expand to all CT and X-ray workflows over the next 18 months. Aidoc is also developing capabilities such as automated draft report creation, advancing toward end-to-end clinical AI workflows.

To learn more, visit https://www.aidoc.com/comprehensive-abdomen-ct-triage

^{[1] K252970 BriefCase-Triage: CARE (Clinical Al Reasoning Engine) Multi-Triage CT Body
[2] Designated as an FDA Breakthrough Device on August 7, 2025}

About Aidoc

Aidoc is a global leader in clinical AI, with the most FDA-cleared computer-aided detection (CAD) solutions in the market. Aidoc powers clinical decision-making for more than 60 million patients each year, delivering real-time AI that eases cognitive load, improves productivity and supports better care across imaging and clinical data.

Built on its proprietary AI Operating System (aiOS™), Aidoc integrates directly into provider workflows at the point of care, helping clinicians prioritize cases more efficiently and make informed decisions with confidence. With adoption across more than 1,600 medical centers worldwide, Aidoc supports health systems as they scale clinical AI responsibly and effectively.

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SOURCE Aidoc