Radiology AI company Harrison.ai has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its acute infarct triage software on noncontrast CT brain scans.
The software is intended to ensure that suspected ischemic stroke patients are prioritized for follow-up, including advanced imaging, according to the company.
Acute infarct triage targets not just large vessel occlusions but infarcts in the anterior cerebral artery, middle cerebral artery, posterior cerebral artery, cerebellum, basilar artery, and watershed border zones. Harrison.ai said the software has achieved 89.2% sensitivity on thin slices and 85.7% on thick slices, with greater than 80% sensitivity and specificity across multiple operating points for both thin and thick slice series.
This is the company's ninth 510(k) submission and second of three Breakthrough Device Designations. With it, both hemorrhagic and ischemic stroke are now covered in one integration, according to the firm.
![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
