Aidoc, an Israeli healthcare AI company, said on Wednesday that it received US Food and Drug Administration clearance for what it described as the healthcare industry’s first comprehensive “foundation model” clinical AI triage workflow, aimed at helping hospitals surface urgent findings earlier during emergency department crowding and imaging backlogs.

The company said the clearance covered 11 newly cleared indications that, together with three previously cleared ones, were combined into a single workflow designed to triage a broad range of acute findings on abdomen CT scans during periods of high clinical demand.

Hospitals have faced sustained pressure from rising emergency department volumes and growing imaging queues, a dynamic that can delay diagnosis when scans are read strictly first-in, first-out. Aidoc said its comprehensive abdomen CT triage approach was intended to act as a safety net by elevating suspected acute findings sooner, supporting earlier clinical decision-making and smoother patient flow.

Aidoc said the same approach could extend beyond emergency departments, including in ambulatory settings where unexpected critical findings sometimes emerge from routine exams that sit in long backlogs. Earlier flagging, the company said, could reduce patient safety risk and support timely follow-up.

The company attributed the expanded clearance to CARE, its self-developed foundation model, and said the FDA decision marked the first clearance of a “double-digit” set of acute indications powered by a single foundation model.

The American FDA.
The American FDA. (credit: SHUTTERSTOCK)

“This clearance validates Aidoc’s foundation-model approach to delivering comprehensive clinical AI at scale,” the company said in its announcement, adding that it believed the breadth and workflow integration represented a step toward wider adoption in busy imaging environments.

Aidoc also highlighted performance figures from an FDA-reviewed pivotal study, saying the 11 newly cleared indications achieved a mean sensitivity of 97% and a mean specificity of 98%, with higher peak values in certain settings. The company said the system produced “roughly an order-of-magnitude reduction” in false alerts compared to leading single-condition solutions, a metric that can matter for clinician trust when AI tools are added to already crowded workflows.

“The ability to bring key acute conditions together into a single workflow is a fundamental shift in how radiology departments operate,” said Dr. Heidi Beilis, chief medical officer of diagnostics at WellSpan Health, in a statement provided by the company. “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.”

Aidoc said the comprehensive abdomen CT triage workflow would be delivered through its aiOS platform, which it described as an enterprise AI operating system built to support deployment and oversight at scale. The company said aiOS includes data normalization, continuous performance monitoring, and governance tools meant to help health systems deploy multi-condition clinical AI without reworking infrastructure.

The firm also said that more than 100 million patient cases had been analyzed on its platform, positioning aiOS as one of the most widely deployed clinical AI systems in healthcare.

Healthcare systems expanding use of AI capabilities in multiple fields

“Health systems are increasingly looking to AI to improve access and tackle their most pressing priorities,” said Elad Walach, Aidoc’s CEO and co-founder, in the company statement. “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.”

Walach said the clearance combined “unprecedented breadth and accuracy,” and that the company planned to continue partnering with clinicians to expand its clinical AI footprint.

Aidoc said its CARE roadmap was expected to broaden beyond abdomen CT, with plans to expand to all CT and X-ray workflows over the next 18 months. The company also said it was developing capabilities such as automated draft report creation, part of a push toward more end-to-end AI-supported clinical workflows.

The announcement came amid wider interest in using AI to manage radiology volume and reduce delays in time-sensitive diagnosis. While AI tools can flag suspected findings faster than traditional queues allow, hospitals and regulators have emphasized the need for high performance, low false alert rates, and clear governance so clinicians can trust results and understand how outputs fit into standard care.

Aidoc framed Wednesday’s clearance as an attempt to address those concerns by consolidating multiple indications into one workflow, rather than layering separate single-condition tools that can add complexity and noise.