HALO
Nico.Lab B.V.HALO is an AI-powered notification software that analyzes brain CT angiograms to detect signs of suspected intracranial Large Vessel Occlusion (LVO). It helps clinicians by promptly notifying appropriate medical specialists to facilitate quicker evaluation and treatment of stroke patients, improving emergency care and patient outcomes.
Intended Use
HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and directly notify an appropriate medical specialist. It facilitates evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing CT angiograms acquired in an acute setting, and sends notification if a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) is identified.
Technology
HALO uses artificial intelligence algorithms with a database of images to analyze CT angiogram images of the brain. The software sends a notification email to the specialist identifying the study of interest and provides a link to a DICOM Web viewer allowing users to review the images. Notification time is defined as time from image upload to the cloud to availability of AI results and notification.
Performance
Performance testing included validation comparing the device to a predicate device with substantially equivalent clinical condition detection. The device was tested on CT images from GE Healthcare and Philips scanners, with clinical testing to confirm notification accuracy and timeliness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/9/2021
29 days - 2
FDA Approval
7/8/2021
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