MlHealth 360 recently announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for Scaida BrainCT-ICH, which is described by the company as an artificial intelligence (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 USA, according to mlHealth.
A recent company press release states that, 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 computed tomography (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—with the goal of ensuring that life-threatening findings are reviewed first rather than sitting in a queue due to high case volumes.
For hospital systems, Scaida BrainCT-ICH delivers immediate return on investment (ROI) by optimising existing resources, mlHealth 360 further claims.
“We engineered this tool to be a force multiplier for radiologists, not a distraction,” said Mahesh Shankar, director of advanced analytics and 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.”
According to mlHealth 360, key operational benefits of Scaida BrainCT-ICH include: speed, with an average processing time of 5.97 seconds ensuring no workflow delays; integration, as it is able to seamlessly integrate with existing picture archiving and communication system (PACS) and radiology information system (RIS) environments; and resource allocation, owing to reduced time-to-read for high-acuity cases during peak emergency room (ER) hours.
“This US FDA clearance is an important validation of our approach to building a scalable intelligence layer for modern radiology,” added Kumar Surender Sinwar, founder and chief executive officer (CEO) of mlHealth 360. “ICH triage represents one of the most time-sensitive challenges in acute care. With this foundation in place, we are developing expanded capabilities across chest, abdominal and whole-body imaging to support health systems worldwide.”
The solution’s recent US FDA clearance is said to be supported by rigorous validation across six US institutions, covering multiple scanner manufacturers—including GE, Siemens and Toshiba—and diverse patient populations. Within these validations, Scaida BrainCT-ICH has demonstrated a specificity of 0.887, a sensitivity of 0.867, and an area under the curve (AUC) of 0.926.
MlHealth notes that Scaida BrainCT-ICH is intended to assist trained radiologists in workflow triage by flagging suspected ICHs, adding that the device does not alter original medical images and is not intended for primary diagnostic interpretation.
