AI Model FDA-Cleared to Triage 14 Conditions

The FDA has cleared 11 new indications for Aidoc’s artificial intelligence (AI) triage tool, aimed at helping hospitals surface urgent findings on abdomen CT scans sooner during periods of high demand.

The tool, dubbed a “foundation model” and an industry first, combines 11 newly cleared indications and three previously cleared ones into a single workflow. The ability to triage abdomen CT could act as a “safety net” by supporting timely clinical decision-making, the company said in its announcement.

The same approach could extend beyond emergency departments, including in ambulatory settings where unexpected findings sometimes emerge from routine exams that sit in long backlogs. 

“Staffing growth is too slow to match the surge in demand,” according to the company. “With facility capacity fixed and volume rising, the only immediate operational lever is shifting from linear queues to acuity-based prioritization.”

The abdomen CT triage is delivered through Aidoc aiOS, the company’s enterprise AI operating system, which has analyzed more than 100 million patient cases to date.

New Indications, Pivotal Study

According to Tom Valent, Aidoc’s chief business officer, the new indications include appendicitis, acute diverticulitis, abdominal-pelvic abscess, small and large bowel obstruction, obstructive kidney stone, intestinal ischemia and/or pneumatosis, kidney injury, liver injury, spleen injury, and pelvic fracture.

Previously cleared indications include abdominal aortic measurement, aortic dissection, and intra-abdominal free air.

In the FDA-reviewed pivotal study, the 11 newly cleared indications achieved a mean sensitivity of 97% (up to 98.5% in certain settings) and a mean specificity of 98% (up to 99.7%). The company said, “[T]he solution delivers markedly improved signal quality, with roughly an order-of-magnitude reduction in false alerts compared to best-in-class, single-condition solutions.”

^“Aidoc is starting to implement the system for early adopter customers, while wide availability will be in the middle of the year,” Valent told Medscape Medical News. “Next, Aidoc aims to expand to similar comprehensive triage for additional body parts in CT and XR [x-ray]. Following that will be auto report draft creation: automating a full radiologist report as a draft for the radiologist to confirm and finalize.”

https://www.medscape.com/viewarticle/ai-model-fda-cleared-triage-14-conditions-2026a10002a0