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.
