HALO
NICo-Lab B.V.HALO is a cloud-based artificial intelligence software that helps medical specialists by analyzing brain CT angiograms to detect signs of large vessel occlusion, a serious condition associated with stroke. It runs alongside the standard imaging workflow and sends alerts to specialists to expedite patient evaluation and care, improving stroke diagnosis and treatment speed.
Intended Use
HALO is a notification only cloud-based image processing software using AI algorithms to analyze CT angiograms of the brain for patients suspected of stroke. It identifies patterns suggestive of intracranial large vessel occlusion (LVO) and notifies a medical specialist to facilitate evaluation.
Technology
HALO is a cloud-based AI software that processes brain CT angiogram images to detect suspected large vessel occlusion. It does not mark or highlight lesions directly on images but sends a notification with a link to a DICOM web viewer to allow specialists to review images remotely. It operates independently and sends alerts in parallel to standard care workflows.
Performance
Non-clinical software testing and a multi-center retrospective clinical study demonstrate HALO's performance is substantially equivalent to the predicate device ContaCT. The clinical study showed sensitivity of 91.1% and specificity of 87.0% for detection of large vessel occlusion, with notification times around 4.5 minutes, supporting its safety and effectiveness as a triage tool for stroke patients.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/1/2020
7 months - 2
FDA Approval
11/20/2020
Other devices from NICo-Lab B.V.
- StrokeViewer Perfusion2023 • 510K
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