FDA clears Aidoc’s foundation-model AI for broad clinical triage
The system flags multiple acute conditions from CT scans within one unified platform.
Aidoc has received clearance from the U.S. Food and Drug Administration for what it describes as the healthcare industry’s first comprehensive AI triage solution. The clearance covers a single system capable of identifying a broad range of acute findings from abdominal CT scans within one unified workflow, an approach intended to address mounting pressures on emergency departments and radiology services.
The newly cleared system combines 11 acute indications with three previously cleared ones, allowing radiology departments to triage multiple critical conditions simultaneously rather than relying on separate, single-purpose AI tools. The technology is built on CARE, Aidoc’s internally developed foundation model, and is designed to surface urgent findings earlier in imaging queues that are typically reviewed on a first-in, first-out basis.
Emergency departments have faced sustained strain as patient volumes rise and imaging backlogs grow, often delaying diagnoses of time-sensitive conditions. Aidoc’s comprehensive triage approach is intended to act as a clinical “safety net,” prioritizing scans with acute findings during periods of high demand and supporting faster clinical decision-making. The same approach is also aimed at ambulatory settings, where routine imaging studies can sit in backlogs despite occasionally containing unexpected critical findings.
According to Aidoc, the FDA clearance represents the first approval of a double-digit set of acute indications powered by a single AI foundation model. In the pivotal study reviewed by regulators, the 11 newly cleared indications demonstrated a mean sensitivity of 97 percent, reaching as high as 98.5 percent, and a mean specificity of 98 percent, with some indications reaching 99.7 percent. The company says the system achieved roughly an order-of-magnitude reduction in false alerts compared with leading single-condition AI solutions, a key consideration for real-world clinical adoption.
The solution is delivered through Aidoc’s aiOS platform, an enterprise AI operating system designed to support large-scale clinical deployment through data normalization, continuous performance monitoring, and governance tools. Aidoc says its platform has been used to analyze more than 100 million patient cases.
Aidoc has raised $370 million to date, including $150 million last July.
