Brainomix 360 Triage Stroke

Brainomix Limited

510k11/21/2023

FDA #

K232496

Product Code

QAS

Panel

Radiology

Modality:CT Task:Triage Body Region:Neurological Target Condition:Large Vessel Occlusion

Brainomix 360 Triage Stroke is an AI-powered radiological software that analyzes non-contrast head CT scans to detect suspected large vessel occlusions and intracranial hemorrhages. It helps clinicians by prioritizing and notifying cases that require urgent attention, improving workflow efficiency in the acute stroke setting. The device presents notifications through a web interface or mobile app, but is not intended for primary diagnosis and should be used alongside standard clinical assessments.

Intended Use

Radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH).

Technology

The device is a standalone software running on physical or virtual servers compliant with DICOM standards. It uses advanced machine learning algorithms and AI to analyze non-contrast CT imaging for LVO and ICH detection. Notifications of suspected findings are delivered in parallel to standard care via a web interface or mobile app. The device performs image preprocessing and registration without altering the original images and does not mark or highlight the images. It supports Siemens, GE, and Philips scanners.

Performance

Retrospective clinical performance study on 267 NCCT cases showed sensitivity of 92.5% for ICH and 68.75% for LVO, with specificity of 87.22% and 89.57%, respectively. Reader study demonstrated non-inferiority to radiologists for LVO detection. The device met an acceptability criterion for notification speed with a time-to-notification range between 62 and 134 seconds. Subgroup analyses confirmed consistent performance across age, gender, slice thickness and scanner manufacturer.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
8/17/2023
3 months
2
FDA Approval
11/21/2023

Other devices from Brainomix Limited

Ready to Sharpen Your Edge?

Join hundreds of your 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.