Head CT interpretation

The following features are FDA and CE cleared:

Clinical decision support with automated Head CT AI Interpretation.
Segregates, triages & notifies about critical Head CT scans.
Detects several abnormalities: 4 findings are FDA cleared, which are ICH, cranial fracture, midline shift and mass effect - all other findings are CE cleared.
Localizes lesions to anatomical structure.
Quantifies reports with ICH volume and midline shift measurements.
Provides pre-populated templates for radiology reports.
Screens head CT scans for signs of intracranial hemorrhage and its subtypes, cranial fractures, mass effect, and midline shift, prioritizing them for clinical review.
The presence of any one of the four abnormalities trigger a status flag

that is displayed on the radiology worklist as ‘Critical’ and may be used as a reference by

the end-user when deciding which study to read next.

The following features are CE marked only:

Intracranial Hemorrhages: Any type of bleeding within the cranial vault, including

brain parenchyma, and meningeal space. For each type of hemorrhage, the software detects, and localizes the following type of suspected bleeding.

Epidural hemorrhage
Subdural hemorrhage
Subarachnoid hemorrhage
Intraparenchymal hemorrhage
Intraventricular hemorrhage
Cranial Fractures: One or more linear lucencies compatible with fracture in an inappropriate area of the cranium, traversing the entire area of the cranial bone. The software detects the suspected cranial fracture and localizes it with a bounding box.
Mass Effect: A visible compression or displacement of adjacent structures extending across at least 5 mm, including compression of the brain parenchyma, effacement of sulci or ventricles, displacement of brain midline, or herniation of brain structures as a result of an underlying pathology.
Midline Shift: Horizontal shift of the brain > 5 mm past the center line as seen on axial brain images.

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