Brainomix 360 Triage ICH uses an artificial intelligence algorithm to analyze non-contrast CT images of the brain to identify potential intracranial hemorrhages and notify appropriate medical specialists. The device is described as a notification-only, parallel workflow tool designed for use by hospitals and trained clinicians.
Brainomix 360 Triage ICH Indications
Specifically, the device is intended to be used to triage non-contrast CT images of the brain acquired from adult patients in the acute setting within 24 hours of the onset of the acute symptoms or where this is unclear since the last known well-time. It is not suitable for other imaging modalities or contrast-enhanced images. The device is not intended to detect isolated subarachnoid hemorrhage.
Development
This device, which Brainomix Limited developed, received premarket authorization from the FDA on July 27, 2023.
Reference
FDA. n.d. “Brainomix 360 510(k) Premarket Notification.” Accessed February 12, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231195.