Artificial intelligence (AI) software developer Brainomix has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its flagship e-ASPECTS stroke imaging software.
The software application assesses non-contrast CT scans and automatically generates an Alberta Stroke Program Early CT Score (ASPECTS). It also provides an overlaid heatmap to assist clinicians in assessing the output, according to the vendor.
The Oxford, U.K.-based company said that it has established a U.S. field team to introduce its Brainomix 360 platform to stroke centers in the U.S. and to provide dedicated support. It has also recently formed a partnership with fellow AI software developer Blackford.
![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)