Aidoc Wins FDA Nod for Comprehensive Foundation Model AI

Aidoc, a pioneer in clinical artificial intelligence (AI), has obtained U.S. Food and Drug Administration (FDA) clearance for its comprehensive AI triage solution.

The solution aims to enable health systems to surface critical findings earlier and reduce delays in patient flow amid emergency department (ED) crowding and imaging backlogs. The breakthrough was made possible through CARE, Aidoc’s self-developed AI foundational model.

This solution brings 11 newly cleared indications and three previously cleared indications together in one workflow, allowing triage of a variety of acute findings during high clinical demand.

Aidoc’s shidt to comprehensive triage of abdomen CT offers a safety net to surface acute findings earlier. The same safety net extends to ambulatory settings, where unexpected critical findings may emerge from routine exams sitting in lengthy backlogs.

The FDA nod validates Aidoc’s foundation model approach to delivering comprehensive clinical AI at scale. According to the company, it represents the first FDA clearance of a set of double-digit acute indications powered by a single foundation model. The solution provides improved signal quality, with about an order of magnitude reduction in false alerts compared to the best single-condition solutions.

In an FDA-reviewed pivotal study, the 11 indications achieved average sensitivity of 97% and average specificity of 98%, enabling the metrics needed for real-world adoption.

“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 abdomen chest CT solution is delivered through Aidoc aiOS, the company’s enterprise AI operating system. aiOS sustains AI performance at foundation model scale through data normalization, continuous performance monitoring, and built-in governance. This lets health systems deploy and manage multi-condition clinical AI without re-architecting infrastructure.

“Health systems are increasingly looking to AI to improve access and tackle their most pressing priorities,” said Elad Walach, co-founder and CEO 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.