The U.S. Food and Drug Administration (FDA) has approved the first comprehensive AI triage solution for the healthcare sector, according to Aidoc, the pioneer and world leader in clinical AI. This allows health systems to reveal important findings sooner and minimize patient flow delays in the face of ED overcrowding and imaging backlogs. CARETM, Aidoc’s in-house AI foundation model, enabled this innovation. The method allows for the triage of a variety of acute findings during periods of high clinical demand by combining three previously cleared indications and eleven recently cleared indications into a single process.
EDs are under constant strain as imaging backlogs and patient loads increase, causing delays and overcrowding. Aidoc’s transition to comprehensive triage of abdominal CT offers a safety net that reveals acute abnormalities sooner, facilitating prompt clinical decision-making and enhancing patient flow, as ED imaging is usually reviewed first-in, first-out.
The same safety net also applies to ambulatory settings, where routine tests that are languishing in long backlogs may provide unexpectedly important discoveries. The approach lowers the danger to patient safety and facilitates prompt follow-up by identifying these situations early.
Aidoc’s foundation-model approach to providing full clinical AI at scale is validated by this approval. It is the first set of double-digit acute indications powered by a single foundation model to receive FDA certification. When compared to best-in-class, single-condition solutions, the solution produces noticeably better signal quality with an order-of-magnitude decrease in false warnings. The 11 indications in the FDA-reviewed pivotal research attained a mean sensitivity of 97% (up to 98.5%) and a mean specificity of 98% (up to 99.7%), allowing for the safety, quality, and dependability necessary for practical use.
“The ability to bring key acute conditions together into a single workflow is a fundamental shift in how radiology departments operate,” stated Heidi Beilis, MD, FACR, 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.”
The company’s corporate AI operating system, Aidoc aiOSTM, provides the complete abdominal CT triage solution. Through data normalization, ongoing performance monitoring, and integrated governance, aiOS maintains AI performance and impact at foundation-model size, allowing health organizations to implement and oversee multi-condition clinical AI without re-architecting infrastructure. The most extensively used clinical AI platform in healthcare is aiOS, which has studied over 100 million patient cases.
“Health systems are increasingly looking to AI to improve access and tackle their most pressing priorities,” stated Elad Walach, CEO and co-founder of Aidoc. “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.”
Over the following 18 months, it is anticipated that the CARE solution roadmap will be extended across all CT and X-ray operations. Aidoc is also working on end-to-end clinical AI processes by creating features like automated draft report creation.
Disclaimer:
The information contained in this article is for educational and informational purposes only and is not intended as a health advice. We would ask you to consult a qualified professional or medical expert to gain additional knowledge before you choose to consume any product or perform any exercise.
