FDA Issues Breakthrough Device Designation for AI-Powered Multi-Triage System for Computed Tomography

The Food and Drug Administration (FDA) has issued a breakthrough device designation for an emerging platform that enables artificial intelligence (AI)-enabled triage for a variety of conditions on computed tomography (CT) scans.

Employing Clinical AI Reasoning Engine (CARE), a clinical-grade foundation model, the multi-triage system reportedly allows detection of a variety of life-threatening conditions on CT within a single workflow, according to Aidoc, the developer of the multi-triage platform.

Aidoc maintained that the multi-triage system, which would be available through Aidoc’s aiOS enterprise imaging platform, may have a significant impact in helping to address the widening gap between rising imaging volume in emergency room settings and radiologist shortages.

“With this designation and our ecosystem of specialized partners, we can deliver a broader set of solutions across many service lines. CARE's ability to detect, characterize, measure, and compare findings underpins both current and in-development applications from triage to report drafting," said Elad Walach, the co-founder and CEO of Aidoc. "We are tackling this from multiple angles, developing innovations in parallel and, as each is FDA cleared, bringing it to market - delivering valuable, safe solutions while building toward the next milestone.”