Scaida BrainCT-ICH

by mlHealth 360  · Based in Canada → — Transforming the future of medical imaging through secure, HIPAA-compliant, cloud-native solutions.
Emergency Medicine Neurosurgery Radiology

Regulatory Status Disclosed

Overview

Scaida BrainCT-ICH is an FDA-cleared AI-powered software solution developed by mlHealth 360, a global healthtech company transforming radiology. This specialized module is designed for the rapid triage and notification of suspected intracranial hemorrhage (ICH) on non-contrast head CT scans in adult patients (ages 22 and above).

The tool integrates seamlessly into existing hospital PACS and RIS workflows, analyzing CT images immediately after acquisition and delivering results in an average of 5.97 seconds. By flagging suspected urgent cases, Scaida BrainCT-ICH helps prioritize a radiologist’s worklist, ensuring that life-threatening findings are reviewed sooner and alleviating operational strain in emergency departments and radiology units. It detects various ICH subtypes, including intraparenchymal, subdural, intraventricular, subarachnoid, and extradural/epidural hemorrhages, and identifies critical indicators such as midline shifts, hyperdense vessels, and ventricular compression.

Scaida BrainCT-ICH boasts high accuracy with a sensitivity of 0.867 and a specificity of 0.887, minimizing false positives to reduce alert fatigue. The software acts as an assistive tool for trained radiologists, providing workflow triage support without altering original medical images or offering primary diagnostic interpretation. It is a cloud-based solution, offering flexibility, scalability, and accessibility for healthcare professionals.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered detection of intracranial hemorrhage subtypes (IPH, SDH, IVH, SAH, EDH)
  • Rapid processing time (average 5.97 seconds)
  • Workflow triage and prioritization of urgent cases
  • Seamless integration with existing PACS and RIS workflows
  • High sensitivity (0.867) and specificity (0.887)
  • Minimizes false positives to reduce alert fatigue
  • Cloud-based solution for flexibility and scalability
  • Does not alter original medical images or provide primary diagnostic interpretation
  • Identifies critical indicators like midline shifts, hyperdense vessels, ventricular compression
  • Trained on diverse datasets from multiple manufacturers (GE, Toshiba, Siemens) and institutions

Use Cases

  • Emergency response and trauma units for rapid assessment
  • Neurology and stroke centers for timely intervention
  • Telestroke and teleradiology networks for remote expertise
  • Assisting radiologists in managing high imaging volumes
  • Prioritizing time-sensitive studies in acute care settings
  • Enhancing diagnostic efficiency and consistency in radiology departments

What Physicians Need to Know

Stroke Detection Speed
Scaida BrainCT-ICH analyzes non-contrast head CT scans and identifies suspected intracranial hemorrhage (ICH) in an average of 5.97 seconds after image acquisition.
Triage Prioritization Speed
Scaida BrainCT-ICH processes scans in an average of 5.97 seconds, ensuring no workflow delays. When a suspected hemorrhage is identified, the AI alerts the care team and moves the study to the top of the radiologist's worklist, prioritizing life-threatening findings.
Physician Tip

Scaida BrainCT-ICH is designed to be a force multiplier for radiologists, not a replacement for clinical judgment. It assists in workflow triage by flagging suspected intracranial hemorrhages, ensuring that critical cases are reviewed first. The high specificity (0.887) helps minimize false positives, reducing alert fatigue and building trust in the notifications. The device does not alter original medical images and is not intended for primary diagnostic interpretation. It is intended for use in adult patients (ages 22 and above).

Scaida BrainCT-ICH seamlessly integrates with existing Picture Archiving and Communication Systems (PACS) and Radiology Information Systems (RIS) environments. It connects with DICOM web services or other imaging systems to upload scans and return results in compatible formats. The software is designed for scalable deployment across both cloud and on-premises environments.

Details

Category Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Unknown
DeploymentCloud and on-premises environments, seamlessly integrates with existing hospital systems (PACS and RIS) and third-party worklist applications.
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Emergency Medicine, Neurosurgery, Radiology

What the Web Says

Scaida BrainCT-ICH is an AI-powered software solution developed by mlHealth 360 that has received U.S. FDA 510(k) clearance for triaging suspected intracranial hemorrhage (ICH) on non-contrast head CT scans. It is designed to assist trained radiologists by automatically analyzing scans immediately after acquisition, flagging suspected hemorrhages, and moving these critical cases to the top of the radiologist's worklist to ensure timely review. The system boasts a rapid processing time of approximately 5.97 seconds and aims to minimize false positives to combat alert fatigue.

Overall: Positive

Strengths

  • Rapid processing time (average of 5.97 seconds) ensures no workflow delays.
  • Minimizes false positives with a specificity of 0.887, reducing alert fatigue for radiologists.
  • Seamlessly integrates with existing Picture Archiving and Communication System (PACS) and Radiology Information System (RIS) environments.
  • Automates prioritization of critical cases, ensuring life-threatening findings are reviewed first.
  • Designed to be a force multiplier for radiologists, optimizing existing resources and delivering immediate return on investment (ROI) for hospital systems.
  • Validated across diverse patient populations and multiple scanner manufacturers (GE, Siemens, Toshiba) in six U.S. institutions.

Limitations

  • Not intended for primary diagnostic interpretation; it is an assistive tool for workflow triage.
  • Does not alter original medical images.
  • Does not provide ICH subclassification to the user.
  • Not intended for use in patients under 22 years of age.
  • The device has no user interface and is a software-only device that has no contact with the patient.

Based on reviews from: neuronewsinternational.com, fda.gov, auntminnie.com, healthandtechnologydistrict.com, xtalks.com, diagnosticimaging.com, onemednet.com, reddit.com, princegeorgenow.com, kelownanow.com, nih.gov, healthmanagement.org, healthcareaiops.com, microsoft.com, peacearchnews.com, manilatimes.net

Last updated: 2026-10-31

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Press & Coverage

auntminnie.com
mlHealth 360 secures FDA 510(k) for ICH triage tool
mlHealth 360 received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Scaida BrainCT-ICH AI-powered triage software, intended to assist radiologists in flagging suspected intracranial hemorrhages (ICH) and prioritizing critical cases.
2025-12
newswire.ca
mlHealth 360 Receives FDA Clearance for Scaida BrainCT-ICH: Canada's First AI Solution for Intracranial Hemorrhage Triage
mlHealth 360 announced that the U.S. FDA granted 510(k) clearance for Scaida BrainCT-ICH, making it the first Canadian-developed AI solution for intracranial hemorrhage triage cleared for clinical use in the United States.
2025-12
neuronewsinternational.com
“Canada's first AI solution for ICH triage” gains US FDA clearance
mlHealth 360's Scaida BrainCT-ICH, an AI-powered triage solution for intracranial hemorrhage, has received 510(k) clearance from the US FDA, marking it as the first Canadian-developed AI solution of its kind to be cleared for clinical use in the USA.
2025-12
diagnosticimaging.com
FDA Clears AI-Powered CT Triage Software for Intracranial Hemorrhage
The FDA has granted 510(k) clearance for Scaida BrainCT-ICH software, which provides AI-powered evaluation of head CT scans for possible ICH in 5.97 seconds after image acquisition.
2025-12
prnewswire.com
mlHealth 360 Receives FDA Clearance for Scaida BrainCT-ICH: Canada's First AI Solution for Intracranial Hemorrhage Triage
mlHealth 360 announced on December 4, 2025, that it received FDA clearance for Scaida BrainCT-ICH, an AI solution for intracranial hemorrhage triage.
2025-12
xtalks.com
FDA Clears mlHealth 360’s AI Software for ICH Triage
The FDA has cleared mlHealth 360's Scaida BrainCT-ICH, an AI software device designed to triage suspected intracranial hemorrhage on non-contrast head CT scans, marking the first Canadian-developed AI system for ICH triage cleared by the agency.
2025-12
g-medtech.com
FDA Clears mlHealth 360's Scaida BrainCT-ICH
The FDA has cleared mlHealth 360's Scaida BrainCT-ICH, making it the first Canadian-developed AI solution for intracranial hemorrhage triage to enter clinical use in the US.
2025-12
stocktitan.net
OneMedNet Real-World Data Supported mlHealth 360 in Obtaining FDA 510(k) Clearance for Scaida BrainCT-ICH Software
OneMedNet announced that its regulatory-grade Real-World Data supported mlHealth 360 in obtaining FDA 510(k) clearance for Scaida BrainCT-ICH software, an AI-powered solution for rapid detection of intracranial hemorrhage.
2026-01

Videos

Product demos, reviews, and walkthroughs for Scaida BrainCT-ICH.

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Frequently Asked Questions

Scaida BrainCT-ICH is an AI-powered triage solution designed to analyze non-contrast head CT scans for suspected intracranial hemorrhage (ICH). It assists neurologists by flagging urgent cases and moving them to the top of a radiologist's worklist, aiming to reduce time-to-read for high-acuity cases and optimize existing resources.
Scaida BrainCT-ICH has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for clinical use in US hospital settings. It is intended to assist trained radiologists in workflow triage by flagging suspected ICH and is not for primary diagnostic interpretation.
Scaida BrainCT-ICH is intended for adult patients (ages 22 and above) and analyzes non-contrast head CT images. It identifies cases with suspected ICH but does not provide subclassification of ICH types. The device does not alter original medical images and is not intended to be used as a diagnostic device.
Scaida BrainCT-ICH is designed to seamlessly integrate with existing Picture Archiving and Communication System (PACS) and Radiology Information System (RIS) environments. It processes each scan in approximately six seconds, aiming to flag urgent findings without slowing routine workflow.
Yes, there are other AI solutions in the market for intracranial hemorrhage detection and triage. Some examples include Aidoc and Viz.ai, which are also commercially available AI software for computer-aided triage and notification.
Scaida BrainCT-ICH has demonstrated a sensitivity of 0.867 and a specificity of 0.887, with an area under the curve (AUC) of 0.926. This performance was validated across multiple scanner manufacturers and diverse patient populations.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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