mlHealth 360 Secures FDA Clearance for Scaida BrainCT-ICH, Canada’s First AI Tool for ICH Triage
Langley, Canada-based mlHealth 360 has received FDA 510(k) clearance for Scaida BrainCT-ICH, an AI-based triage tool developed to support emergency radiology teams by identifying suspected intracranial hemorrhage on non-contrast CT scans. The authorization makes it the first Canadian-developed AI system for ICH triage approved for the U.S. market, marking a significant milestone for the company and for AI innovation in Canadian healthcare.
Radiology departments continue to face mounting pressure as imaging volumes rise and staffing shortages intensify. Delays in reviewing emergency scans can have serious consequences, particularly in cases of intracranial bleeding where rapid intervention is critical. Scaida BrainCT-ICH is designed to address this challenge by analyzing head CT images immediately after acquisition and automatically flagging studies with a suspected hemorrhage. These flagged cases are moved to the top of the radiologist’s worklist to help ensure that urgent findings receive timely attention.
Mahesh Shankar, Director of Advanced Analytics & Innovation at mlHealth 360, said the goal was to build a system that supports clinicians without contributing to unnecessary alerts. “We engineered this tool to be a force multiplier for radiologists, not a distraction,” he said, noting that the algorithm’s specificity of 0.887 is intended to reduce false positives and maintain trust in the notifications it generates.
The company emphasized that hospitals can integrate Scaida BrainCT-ICH into existing PACS and RIS systems without workflow disruption. The AI processes each scan in an average of 5.97 seconds and aims to reduce time-to-read for high-acuity cases, particularly during peak emergency department hours. Kumar Surender Sinwar, Founder and CEO of mlHealth 360, said the FDA decision “is an important validation of our approach to building a scalable intelligence layer for modern radiology,” and added that the company plans to expand its AI portfolio to other imaging domains.
The FDA clearance followed validation studies across six U.S. clinical sites using CT systems from several major manufacturers. The model demonstrated a sensitivity of 0.867, a specificity of 0.887, and an area under the curve of 0.926. Scaida BrainCT-ICH is intended to assist radiologists by triaging suspected intracranial hemorrhage cases and does not modify medical images or replace diagnostic interpretation.
