FDA OKs Harrison.ai’s Acute Infarct Triage on Non-Contrast CT Brain

Harrison.ai has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for acute infarct triage on non-contrast CT Brain.

The company’s triage covers six vascular territories and mechanisms of infarct, prioritizing ischemic strokes across the brain’s full area. Acute infarct is difficult to identify on non-contrast CT—existing stroke AI focuses on large vessel occlusion (LVO) in one or two vascular territories. The rest, unfortunately, go untriaged.

Instead of CT angiography, Harrison.ai triages on the non-contrast head CT to help ensure suspected ischemic stroke patients are prioritized for follow-up, including advanced imaging sooner. It triages brain tissue injury in ACA, MCA, PCA, cerebellar, basilar, and watershed infarcts, not just vessel occlusions.

“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,” said Dr. Jarrel Seah, Harrison.ai’s chief medical officer and practicing radiologist at Harrison.ai. “That’s why we felt it was important to build it.”

The acute infarct triage achieved up to 89.2% sensitivity on thin slices and 85.7% on thick slices, with more than 80% sensitivity and specificity on multiple operating points for think and thick slice series. Ground truth was established using advanced imaging as the reference standard, meaning the AI was validated against confirmed infarcts that were not guaranteed to be visible on non-contrast CT.

The FDA-reviewed 510(k) submission for this clearance included direct performance comparisons against existing stroke AI approaches. The closest FDA-cleared comparator on non-contrast CT, an LVO triaging device, demonstrated 63.5% sensitivity and 95.1% specificity for identifying vessel occlusion only. Harrison.ai achieved over 80% sensitivity and over 80% specificity over multiple operating points for identifying actual tissue injury across all six vascular territories and mechanisms of infarct.

“Patients who aren’t on a dedicated stroke protocol may experience significant delays before acute infarct is identified. When time is brain, that has real patient impact,” said Dr. Aengus Tran, co-founder and CEO of Harrison.ai. “Thirteen cleared indications and now our second Breakthrough device to reach marketing authorization. We have the most comprehensive FDA-cleared AI triage coverage for non-contrast CT Brain.”