syngo.CT Brain Hemorrhage
Siemens Medical Solutions USA, Inc.syngo.CT Brain Hemorrhage by Siemens Medical Solutions is an AI-powered software that helps radiologists prioritize CT scans suspected of having intracranial or subarachnoid hemorrhages. It analyzes head CT images to flag cases for earlier review, improving workflow efficiency. This software is not for diagnosis but supports clinicians by highlighting urgent cases based on AI detection of hemorrhages.
Intended Use
syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage, also in the subarachnoid space, on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a standalone diagnostic device.
Technology
syngo.CT Brain Hemorrhage is an image-processing software that uses an artificial intelligence algorithm to identify findings suspicious for acute intracranial hemorrhage (ICH) and subarachnoid hemorrhage (SAH) on non-contrast head CT scans. It operates as a notification-only tool, flagging cases for review without marking images or removing cases from the reading queue. It supports analysis of DICOM images from Siemens and other vendors and is compatible with SOMARIS-X and syngo.via platforms.
Performance
The device was validated in a retrospective standalone study with 900 anonymized head CT cases balanced for presence or absence of ICH from multiple US and European sites. Sensitivity for detection of intracranial hemorrhage was 95.0% and specificity was 93.1%. For subarachnoid hemorrhage, sensitivity was 86.1% and specificity was 85.2%. Average processing time per case was 13.34 seconds, comparable to the predicate device. These results support the device's safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/11/2023
7 months - 2
FDA Approval
3/22/2024
Other devices from Siemens Medical Solutions USA, Inc.
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