Scaida BrainCT-ICH
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
Scaida BrainCT-ICH is designed as a 'force multiplier' for radiologists, aiming to minimize false positives to combat alert fatigue and build trust in notifications. It serves as an assistive tool for workflow triage by flagging suspected intracranial hemorrhages and is not intended for primary diagnostic interpretation, nor does it replace clinical judgment.
The software seamlessly integrates with existing hospital PACS (Picture Archiving and Communication System) and RIS (Radiology Information System) environments. It connects with third-party worklist applications via DICOM to receive images and return findings. It is a cloud-based AI module.
Details
| Category | Neurology AI, Radiology & Imaging AI, Triage & ER/ICU AI |
| Pricing | Contact for pricing |
| Deployment | Cloud-based; integrates with PACS/RIS systems via DICOM |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Scaida BrainCT-ICH received FDA 510(k) clearance (K250694) on November 25, 2025. It is intended to assist trained radiologists in workflow triage by flagging suspected intracranial hemorrhages on non-contrast head CT images of adult patients (ages 22 and above). |
| Integrations | |
| EHR | Not specified |
| Specialties | Emergency Medicine, Neurosurgery, Radiology |
What the Web Says
Scaida BrainCT-ICH is an AI-powered software developed by mlHealth 360 designed to triage suspected intracranial hemorrhage (ICH) on non-contrast head CT scans. It received FDA 510(k) clearance in December 2025, making it the first Canadian-developed AI system for ICH triage to be cleared for clinical use in the U.S.. The software aims to alleviate operational strain in radiology departments by prioritizing urgent cases, analyzing scans in approximately six seconds, and seamlessly integrating with existing PACS and RIS workflows.
Overall: PositiveStrengths
- Automates prioritization of critical cases, reducing delays in reviewing time-sensitive studies.
- Minimizes false positives with a specificity of 0.887, helping to combat alert fatigue among radiologists.
- Rapid processing time of approximately 5.97 seconds, ensuring no workflow delays.
- Seamlessly integrates with existing PACS and RIS environments.
- High sensitivity of 0.867 for detecting intracranial hemorrhage.
- Supported by validation data from six U.S. institutions with diverse patient populations and scanner manufacturers.
Limitations
- Not intended for primary diagnostic interpretation; it is an assistive tool for triage.
- Does not provide ICH subclassification to the user.
- Not intended for use in patients under 22 years of age.
- Lower detection rates for specific subtypes of ICH have been observed in other AI tools, though not specifically for Scaida BrainCT-ICH, this could be a general concern for such tools.
- Potential for false negatives, as with any AI tool, requiring radiologists to still review all cases per standard of care.
- No direct user interface for the software itself.
Based on reviews from: Xtalks, PR Newswire, AuntMinnie.com, mlHealth360.com, accessdata.fda.gov, Peace Arch News, Barchart.com, PubMed
Last updated: 2026-07-19
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