The FDA has granted clearance to Aidoc for a groundbreaking AI-powered triage platform that detects and prioritizes 14 acute conditions from abdominal CT scans in a single unified workflow.
This development addresses longstanding challenges in emergency departments and outpatient imaging, where delays in reviewing scans can compromise patient outcomes amid rising caseloads and backlogs.
FDA Clears Aidoc’s Comprehensive AI Triage Platform for Abdominal CT Scans
The U.S. Food and Drug Administration (FDA) has approved a first-of-its-kind artificial intelligence solution from Aidoc that integrates the detection of 14 critical acute conditions into one streamlined triage workflow for abdominal computed tomography (CT) scans.
Announced in January 2026, this clearance represents a major advancement in clinical AI, shifting from single-condition tools to a more comprehensive, foundation model-driven approach that promises faster identification of urgent findings and improved workflow efficiency.
Aidoc’s platform, powered by the company’s proprietary Clinical AI Reasoning Engine (CARE) foundation model, combines 11 newly cleared indications with three previously authorized ones. The system flags conditions such as liver injury, spleen injury, bowel obstruction, appendicitis, and other acute abdominal issues that require prompt intervention.
In emergency departments facing high patient volumes, traditional first-in-first-out review processes often delay diagnosis of life-threatening problems. This AI tool acts as a safety net by elevating suspected critical cases higher in the radiologist’s queue, enabling earlier clinical decisions and smoother patient flow.
The same capability extends to ambulatory and outpatient settings, where routine scans can accumulate in large backlogs. Unexpected acute findings in these non-emergent exams sometimes go unnoticed for extended periods, increasing patient safety risks. By prioritizing urgent abnormalities early, the platform supports timely follow-up care and reduces potential harm.
Performance data from pivotal studies submitted to the FDA demonstrated strong results for the 11 new indications. The system achieved a mean sensitivity of 97 percent (with peaks up to 98.5 percent) and a mean specificity of 98 percent (reaching up to 99.7 percent in certain scenarios).
Notably, it delivered roughly an order-of-magnitude reduction in false positives compared to conventional single-condition AI systems. Lower false alert rates help maintain clinician trust, especially in busy radiology environments where excessive notifications can lead to alert fatigue.
Key Benefits in Emergency and Outpatient Care
Emergency departments across the United States continue to grapple with overcrowding, a trend exacerbated by post-pandemic demand surges and staffing shortages. Imaging backlogs contribute to prolonged wait times, which can worsen outcomes for time-sensitive conditions like internal bleeding or organ perforation.
Aidoc’s solution tackles these issues head-on by automating initial triage, allowing radiologists to focus first on high-priority cases without disrupting standard protocols.
In outpatient imaging centers, where exams often involve non-urgent referrals, the tool provides an added layer of protection. Incidental acute findings—such as unsuspected appendicitis during a scan for unrelated abdominal pain—can be flagged promptly, preventing escalation and supporting efficient care coordination.
Dr. Heidi Beilis, Chief Medical Officer of Diagnostics at WellSpan Health, highlighted the platform’s impact. The ability to consolidate multiple acute conditions into a single workflow marks a fundamental shift in radiology operations. WellSpan has integrated various AI tools across its imaging systems, but this comprehensive triage addresses core challenges in workflow management, time-to-diagnosis, and overall patient outcomes.
The Technology Behind the Clearance
Aidoc’s platform operates through its enterprise AI operating system, known as aiOS. This infrastructure enables large-scale deployment with essential features including data normalization, built-in governance, and continuous performance monitoring.
According to Aidoc, aiOS has analyzed over 100 million patient cases, making it one of the most widely implemented clinical AI platforms in healthcare (source: Aidoc official announcement)
The CARE foundation model underpins the entire system, representing a departure from narrow, task-specific AI models. By training on vast datasets, foundation models can handle broader clinical reasoning, paving the way for scalable, multi-condition detection. This clearance stands as the first FDA approval of a comprehensive set of double-digit acute indications powered by a single such model in radiology.
Broader Context in AI Radiology Adoption
The FDA has cleared hundreds of AI-based medical devices in radiology over recent years, but most focus on single findings, such as intracranial hemorrhage or pulmonary embolism.
Deploying multiple single-purpose tools creates integration hurdles, increases alert burden, and complicates clinician workflows. Aidoc’s bundled approach simplifies adoption, offering one cohesive system that covers a wide range of abdominal emergencies.
This milestone aligns with growing healthcare system interest in AI to enhance access, reduce delays, and manage priorities amid resource constraints. Regulators and providers emphasize high accuracy, low false positives, and transparent governance to ensure reliable real-world performance.
Future Roadmap and Implications
Aidoc plans to expand the CARE-powered capabilities beyond abdominal CT scans. The company aims to cover all CT and X-ray workflows within the next 18 months. Additional developments include automated draft report generation, moving toward fully integrated AI-supported clinical processes that could further streamline radiology operations.
As AI continues to mature in medical imaging, solutions like this one signal a transition toward more holistic, efficient diagnostic support. Hospitals adopting such technologies stand to benefit from accelerated diagnoses, better resource allocation, and enhanced patient safety in high-pressure environments.
This FDA clearance underscores the potential of foundation-model AI to transform clinical workflows while maintaining rigorous safety and efficacy standards. With proven performance and scalable infrastructure, the platform positions Aidoc at the forefront of efforts to address persistent challenges in emergency and routine imaging care.