mlHealth 360 has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Scaida BrainCT-ICH AI-powered triage software.
The British Columbia-based firm said its Canadian-developed AI is intended to assist trained radiologists in workflow triage by flagging suspected intracranial hemorrhages (ICH). The system automatically analyzes noncontrast head CT scans, but it is not intended for primary diagnostic interpretation, the company noted.
In its announcement, mlHealth 360 said the software successfully prioritizes critical cases with a specificity of 89%, sensitivity of 87%, area under the curve (AUC) of 0.926, and average processing time of 5.97 seconds.
The firm added that the FDA clearance is supported by "rigorous" validation across six U.S. institutions, covering multiple scanner manufacturers and diverse patient populations.
![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)
