FDA Clears CT-Based AI Triage Platform from Aidoc

The Food and Drug Administration (FDA) has granted 510(k) clearance for a new computed tomography (CT)-based artificial intelligence (AI) triage software, which includes a total of 14 cleared indications.

Emphasizing that the AI triage software was created with the clinical-grade foundation model Clinical AI Reasoning Engine (CARE), Aidoc, the developer of the software, said it can be utilized to improve workflow efficiencies in emergency departments as well as ambulatory settings.

The abdominal CT triage software will be available through the enterprise AI operating system Aidoc aiOS™, according to the company.

Aidoc pointed out that research involving the 11 new cleared indications with the AI triage platform demonstrated a 97 percent mean sensitivity and a 98 percent mean specificity.

"The ability to bring key acute conditions together into a single workflow is a fundamental shift in how radiology departments operate," said Heidi Beilis, M.D., FACR, the 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."