FDA Clears AI-Powered CT Triage Software for Intracranial Hemorrhage

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Scaida BrainCT-ICH software, which reportedly facilitates timely detection of intracranial hemorrhage (ICH) based on head computed tomography (CT) scans.

The Scaida BrainCT-ICH software offers AI-powered evaluation of head CT scans for possible ICH in 5.97 seconds after image acquisition, according to mIHealth 360, the developer of Scaida BrainCT-ICH.

Noting that the triage software can be seamlessly integrated with a facility’s PACS and RIS, mI Health 360 emphasized that Scaida BrainCT-ICH provides 86.7 percent sensitivity, 88.7 percent specificity and a 92.6 percent AUC for detecting ICH.

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