FDA clears 11 new indications for Aidoc's triage solution

Aidoc has secured 11 new indications from the Food and Drug Administration (FDA), bringing a comprehensive body CT triage solution to emergency departments and ambulatory settings to reduce patient backlogs. 

Aidoc, a clinical artificial intelligence company, is trying to solve the root issue of overcrowding in emergency departments and provider offices. The company argues that providers’ operational workflows, which mostly prioritize patients on a "first come, first serve" basis, don’t work well.

Instead of first-in, first-out, Aidoc’s AI triage solution can prioritize scans based on its initial review of the images. Those scans are then moved up in the queue for radiologists to review, allowing acutely ill patients to receive care more quickly.

The new approval from the FDA adds 11 additional indications to the triage solution, helping Aidoc build out its repertoire of regulatory-grade AI technology for imaging. The 11 new indications are powered by Aidoc’s self-built foundation model. 

Aidoc previously had three cleared indications for CT imaging. It now offers a comprehensive body CT triage solution for providers to prioritize patients by medical necessity.

The company built the first cleared foundation model in healthcare, called CARE (Clinical AI Reasoning Engine), which brings a total of 14 indications into one workflow. Aidoc’s enterprise AI platform, Aidoc aiOS, can detect a wide range of acute conditions for emergency departments and ambulatory providers. 

The new indications are also more accurate than other solutions on the market, resulting in less false alerts, Aidoc said in a press release. Based on the FDA-reviewed study, Aidoc’s newest indications achieved a mean sensitivity of 97% and a mean specificity of 98%. 

“The ability to bring key acute conditions together into a single workflow is a fundamental shift in how radiology departments operate,” Heidi Beilis, M.D., chief medical officer of diagnostics at WellSpan Health, said in a statement. “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.”

Aidoc plans to expand its AI-enabled imaging solutions to all CT and X-ray workflows in the next 18 months, executives said in the press release. The company is also developing a solution that will draft reports for providers. 

“Health systems are increasingly looking to AI to improve access and tackle their most pressing priorities,” Elad Walach, CEO of Aidoc, said in a statement. “With CARE, we knew breadth alone wasn’t enough. We were committed to meeting the safety and quality threshold required for real-world clinical use. This FDA clearance, combining unprecedented breadth and accuracy, marks a new era for clinical AI, and we’re excited to partner with physicians to improve patient care worldwide.”

Aidoc, founded in 2016, raised $150 million in new financing back in July backed by General Catalyst and Square Peg. The funding round also was backed by NVentures, Nvidia’s venture capital arm, along with major U.S. health systems Sutter Health, Hartford, Mercy and WellSpan.