Approval marks Harrison.ai's second out of three Breakthrough designations to reach marketing authorization, and 9^th FDA clearance covering a total of 13 radiological findings.

Harrison.ai today announced FDA 510(k) clearance for acute infarct triage on non-contrast CT Brain. Acute infarct is one of the most difficult findings to identify on non-contrast CT. Existing stroke AI focuses on large vessel occlusion in one or two vascular territories. The rest go untriaged. Harrison.ai's triage covers six vascular territories and mechanisms of infarct, prioritizing ischemic strokes across the full geography of the brain.

A different approach to stroke triage

Most stroke AI works on CT angiography (CTA), an advanced scan typically obtained later in the diagnostic workflow. Harrison.ai triages on the non-contrast head CT, the very first scan, helping ensure suspected ischemic stroke patients are prioritized for follow up including advanced imaging sooner. It triages actual brain tissue injury in ACA, MCA, PCA, cerebellar, basilar, and watershed infarcts, not just vessel occlusions.

No other AI has received FDA clearance for acute infarct triage on non-contrast CT Brain. This is not a marginal improvement, but rather a fundamental shift.

"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, Chief Medical Officer and practicing radiologist at Harrison.ai. "That's why we felt it was important to build it."

Performance that changes clinical outcomes

Harrison.ai's acute infarct triage achieved up to 89.2% sensitivity on thin slices and 85.7% on thick slices, with greater than 80% sensitivity and specificity on multiple operating points for both thin 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, a large vessel occlusion (LVO) triaging device, demonstrated 63.5% sensitivity and 95.1% specificity for identifying vessel occlusion only. Harrison.ai achieved greater than 80% sensitivity and greater than 80% specificity over multiple operating points for identifying actual tissue injury across all six vascular territories and mechanisms of infarct. This is a more comprehensive approach and triages stroke in more areas that might not be picked up with an LVO device.

The submission also included comparison to a widely deployed, FDA-cleared CT angiography-based large vessel occlusion triage system as a reference device. That system reported 91.3% sensitivity and 85.6% specificity in its most recent clearance. However, CTA requires contrast injection and is typically obtained after non-contrast CT in the acute stroke workflow. The system identifies vessel occlusion; it is not indicated for triage of acute infarction.

Harrison.ai triages actual ischemic tissue damage on the first scan a patient receives, across all major vascular territories of infarct, which can lead to more suspected strokes being prioritized sooner.

The most comprehensive CT Brain coverage

Combined with seven other FDA-cleared CT Brain findings, Harrison.ai now delivers the most comprehensive critical exam coverage on non-contrast CT Brain of any AI triage platform. Eight findings on a single first-line imaging modality. Both hemorrhagic and ischemic stroke covered in one integration. Harrison.ai is also currently one of only two radiology AI companies with a device eligible for Medicare New Technology Add-on Payment (NTAP).

13 Indications. 3 Breakthroughs.

Harrison.ai's 13 FDA-cleared indications are the product of 9 separate 510(k) submissions, each representing an independent body of clinical and technical evidence built over years of rigorous validation.

Three of our indications have earned FDA Breakthrough Device Designation, and our acute infarct and obstructive hydrocephalus triage and prioritization solutions are among only 15% of FDA Breakthrough devices that have ever received marketing authorization (e.g., 510(k) clearance). The result is the most comprehensive FDA-cleared AI triage coverage for non-contrast CT Brain.

"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, CEO and Co-Founder 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."

About Harrison.ai

Harrison.ai's solutions are available in 40+ countries. They are clinically deployed at 1,000+ customer sites globally, including 40+ NHS Trusts and all public emergency departments in Hong Kong. It is also available to half of all Australian radiologists. With 3,400+ clinicians using our tools, Harrison.ai has impacted more than 7 million patients' lives to date.

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