mlHealth 360 announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K250694) for Scaida BrainCT-ICH, an AI-powered triage solution designed to address critical bottlenecks in acute care radiology.

This clearance establishes Scaida BrainCT-ICH as the first Canadian-developed AI solution for intracranial haemorrhage (ICH) triage to be cleared for clinical use in the United States.

Radiology departments worldwide are experiencing unprecedented imaging demand. As volumes grow, radiologists face increasing cognitive load and burnout, and emergency studies risk sitting unreviewed in a backlog during the very moments when minutes matter most.

Built on the clinical principle that "Time is Brain," Scaida BrainCT-ICH cuts through the noise to support overburdened teams. Functioning as an always-on sentry, the system automatically analyses non-contrast head CT scans immediately after acquisition.

When the AI identifies a suspected haemorrhage, it alerts the care team and moves the study to the top of the radiologist's worklist. This ensures that life-threatening findings are reviewed first, rather than sitting in a queue due to high volume.

For hospital systems, Scaida BrainCT-ICH delivers immediate ROI by optimising existing resources.

"We engineered this tool to be a force multiplier for radiologists, not a distraction," said Mahesh Shankar, Director of Advanced Analytics & Innovation at mlHealth 360. "With a specificity of 0.887, the system is designed to minimise false positives. This combats 'alert fatigue' and ensures that radiologists can trust the notifications they receive.”