The U.S. Food and Drug Administration has cleared the healthcare industry’s first comprehensive artificial intelligence triage solution, Aidoc announced Wednesday, marking a significant step in the use of clinical AI to manage emergency department (ED) crowding and imaging backlogs.
The FDA clearance covers a platform developed by Aidoc that integrates 14 indications—11 newly cleared and three previously authorized—into a single AI-powered workflow. The system, powered by Aidoc’s proprietary CARE foundation model, is designed to help health systems identify critical findings earlier and speed up clinical decision-making during high patient demand.
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Aidoc founders Michael Braginsky (left), Elad Walach and Guy Reiner
(Photo: Guy Shriber)
Aidoc’s tool enables prioritized triage of abdominal CT scans in EDs, where imaging is traditionally reviewed in the order it is received. The AI-driven shift provides what the company describes as a “safety net” to detect acute conditions sooner, helping clinicians improve patient flow and reduce delays.
That same model also applies in outpatient settings, where routine exams may sit in large backlogs. By flagging urgent findings earlier, Aidoc’s solution aims to reduce patient safety risks and support timely follow-up care.
This marks the first FDA clearance of a comprehensive AI solution powered by a single foundation model covering double-digit acute indications. In pivotal studies submitted to the FDA, the tool achieved a mean sensitivity of 97% (up to 98.5%) and specificity of 98% (up to 99.7%), while significantly reducing false positives compared to traditional single-condition systems.
Heidi Beilis, MD, FACR, Chief Medical Officer of Diagnostics at WellSpan Health, said the ability to bring multiple acute conditions into a single workflow represents “a fundamental shift in how radiology departments operate.” Beilis added that the tool directly addresses challenges around workflow management and time-to-diagnosis.
The solution runs on Aidoc’s enterprise AI operating system, aiOS, which supports large-scale deployment through features such as data normalization, built-in governance and performance monitoring. With over 100 million patient cases analyzed, aiOS is currently the most widely implemented clinical AI platform in healthcare, according to the company.
Aidoc CEO and co-founder Elad Walach said the FDA’s approval reflects the company's commitment to pairing clinical breadth with real-world safety and accuracy. “This FDA clearance, combining unprecedented breadth and accuracy, marks a new era for clinical AI,” he said.
The company said its CARE solution roadmap includes plans to expand to all CT and X-ray workflows within the next 18 months and is also working on tools for automated report generation, moving toward fully integrated AI-driven clinical workflows.