Aidoc files FDA submission for multitriage device

Following a successful trial, Aidoc has filed a submission with the U.S. Food and Drug Administration (FDA) for its breakthrough-designated multitriage device.

The triage system, which is powered by Aidoc’s Clinical AI Reasoning Engine (CARE) Foundation Model, identifies cases with acute, time-sensitive abnormalities immediately after scan completion. Trained on multimodal data, CARE is designed to detect and prioritize abdominal conditions.

In the study, the multitriage device demonstrated 97% sensitivity (up to 98.5% at maximum sensitivity) and 98% specificity (up to 99.7% at maximum specificity) across a wide range of abdominal findings.

Aidoc also noted that its aiOS operating system has attained the milestone of analyzing 100 million patient cases. Key attributes of Aidoc aiOS include precision orchestration tailored to hospital, modality, and physician workflow; continuous drift monitoring; and real-time multimodal data integration.

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