mlHealth 360 Receives FDA Clearance for Scaida BrainCT-ICH: Canada's First AI Solution for Intracranial Hemorrhage Triage

• Major Regulatory Milestone: The first Canadian-developed AI for ICH triage receives FDA clearance to enter the U.S. market.
• Operational Value: Automates prioritization of critical cases to alleviate radiologist burnout.
• Workflow Efficiency: High Specificity (0.887) minimizes false alarms; average processing time of 5.97 seconds.

SURREY, BC, Dec. 4, 2025 /PRNewswire/ - mlHealth 360 today 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 hemorrhage (ICH) triage to be cleared for clinical use in the United States.

Addressing the Volume Crisis in Radiology

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.

The Solution: Automated Prioritization

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 analyzes non-contrast head CT scans immediately after acquisition.

When the AI identifies a suspected hemorrhage, 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.

Impact for Healthcare Operations

For hospital systems, Scaida BrainCT-ICH delivers immediate ROI by optimizing 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 minimize false positives. This combats 'alert fatigue' and ensures that radiologists can trust the notifications they receive.".

Key operational benefits include:

• Speed: Average processing time of 5.97 seconds, ensuring no workflow delays.
• Integration: Seamlessly integrates with existing PACS and RIS environments.
• Resource Allocation: Reduces time-to-read for high-acuity cases during peak ER hours.

From Regulatory Milestone to Global Scale

"This FDA clearance is an important validation of our approach to building a scalable intelligence layer for modern radiology," said Kumar Surender Sinwar, Founder & 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."

Validated Performance

The FDA clearance is supported by rigorous validation across six U.S. institutions, covering multiple scanner manufacturers (GE, Toshiba, Siemens) and diverse patient populations.

• Specificity: 0.887
• Sensitivity: 0.867
• Area Under the Curve (AUC): 0.926
• Average Processing Time: 5.97 seconds

Regulatory Intended Use

Scaida BrainCT-ICH is intended to assist trained radiologists in workflow triage by flagging suspected intracranial hemorrhages. The device does not alter original medical images and is not intended for primary diagnostic interpretation.

About mlHealth 360

mlHealth 360 is a global healthtech company transforming radiology with secure, cloud-native AI solutions. Our medical imaging platforms improve reporting speed and healthcare efficiency while integrating seamlessly into existing hospital infrastructure. 

Website: https://mlhealth360.com/

LinkedIn: https://www.linkedin.com/company/mlhealth-360

SOURCE mlHealth 360