Scaida BrainCT-ICH (v1.0)
Mlhealth 360Scaida BrainCT-ICH is an AI-powered software that analyzes non-contrast head CT scans of adult patients to detect suspected intracranial hemorrhages. It helps radiologists by notifying them of potential positive cases to prioritize and triage workflow efficiently, improving timely diagnosis and care without altering original images.
Intended Use
Scaida BrainCT-ICH is a radiological computer aided notification software indicated for use in the analysis of non-contrast head CT images of adult patients (ages 22 and above) to assist trained radiologists in workflow triage by flagging and communicating suspected positive findings of intracranial hemorrhages (ICH).
Technology
The device uses an artificial intelligence algorithm to analyze non-contrast head CT images to identify cases with suspected intracranial hemorrhage. It integrates with third-party worklist applications via DICOM to receive images and return findings. The software-only device does not alter images or remove cases from the queue.
Performance
A retrospective study on 294 cases from multiple US institutions showed the software achieved sensitivity of 86.7% and specificity of 88.7% in detecting intracranial hemorrhages, with an AUC of 0.926, meeting predefined performance criteria compared to the predicate device.
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 7,100+ peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.