FDA Clears Harrison.ai AI Tool for Acute Infarct Triage on Non-Contrast CT Scans

Harrison.ai has received FDA 510(k) clearance for an AI tool that triages acute infarcts on non-contrast CT brain scans, marking the company’s ninth FDA clearance and bringing its total to 13 radiological indications. The approval also represents the second of three Harrison.ai solutions with FDA Breakthrough Device Designation to reach marketing authorization.

Acute infarct is among the most difficult findings to detect on non-contrast CT, and most existing stroke AI systems focus on identifying large vessel occlusions (LVOs) on CT angiography (CTA), typically obtained later in the stroke imaging workflow. Harrison.ai’s approach instead analyzes the first imaging study performed—non-contrast head CT—allowing earlier triage of suspected ischemic stroke cases.

The system evaluates actual brain tissue injury across six vascular territories—anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), cerebellar, basilar, and watershed infarcts—rather than focusing solely on vessel occlusion.

“No other AI has received FDA clearance for acute infarct triage on non-contrast CT brain,” said Dr. Jarrel Seah, chief medical officer and practicing radiologist at Harrison.ai. “Acute infarct on non-contrast CT is one of the hardest findings in radiology. Most radiologists will welcome the help in bringing these cases to the front of the queue.”

In clinical validation, the AI achieved up to 89.2% sensitivity on thin-slice CT scans and 85.7% on thick-slice scans, with greater than 80% sensitivity and specificity across multiple operating points. Ground truth was established using advanced imaging as the reference standard.

The FDA submission also included comparisons with existing stroke AI tools. An FDA-cleared non-contrast CT LVO triage system demonstrated 63.5% sensitivity and 95.1% specificity for vessel occlusion detection only. A widely used CTA-based LVO triage system reported 91.3% sensitivity and 85.6% specificity, but CTA requires contrast injection and is typically performed after non-contrast CT.

By triaging ischemic tissue damage directly on the first scan, Harrison.ai’s system may allow more suspected strokes to be prioritized earlier in the diagnostic pathway.

With this clearance, Harrison.ai now offers eight FDA-cleared findings on non-contrast CT brain, covering both hemorrhagic and ischemic stroke in a single workflow integration—currently the most comprehensive AI triage coverage for this imaging modality.

“Patients who aren’t on a dedicated stroke protocol may experience significant delays before an acute infarct is identified,” said Dr. Aengus Tran, CEO and co-founder of Harrison.ai. “When time is brain, that has real patient impact.”