FDA Clears Aidoc Foundation-Model AI That Triages 14 Acute Findings on Abdominal CT

Aidoc said on January 21 that the U.S. Food and Drug Administration has cleared an artificial intelligence triage solution for abdominal CT scans that brings 11 newly cleared indications and three previously cleared ones together in a single workflow. The company's announcement was read via DotMed, which republished it.

The software is built on CARE, the AI foundation model Aidoc developed itself, and is intended to flag scans with acute findings so they can be read sooner, the company said. Aidoc did not give a 510(k) number in its release, and it describes the product as the health care industry's first comprehensive AI triage solution.

How it is meant to work

Emergency department imaging is typically read first in, first out, and Aidoc said triaging abdominal CT across many conditions at once provides a safety net that surfaces acute findings earlier when departments are crowded and imaging backlogs grow. The company said the same approach applies to outpatient settings, where routine exams can sit in long queues while containing unexpected critical findings.

The approach lets radiology departments triage multiple critical conditions at once rather than relying on separate, single-purpose AI tools, Calcalist's CTech reported.

Reported performance

In the FDA-reviewed pivotal study, the 11 newly cleared indications achieved a mean sensitivity of 97%, reaching up to 98.5%, and a mean specificity of 98%, reaching up to 99.7%, according to the company. Aidoc also said the system produced roughly an order-of-magnitude reduction in false alerts compared with leading single-condition AI products. These figures come from the company's announcement and have not been published in a journal.

Aidoc said the clearance is the first FDA clearance of a double-digit set of acute indications powered by a single foundation model.

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

The solution is delivered through aiOS, Aidoc's enterprise AI operating system, which the company says handles data normalization, continuous performance monitoring and governance and has been used to analyze more than 100 million patient cases.

Aidoc has raised $370 million in total funding to date, according to CTech.