More than a decade after InfraScan’s technology was initially approved by the FDA to detect internal bleeding in the brains of adult patients with head injuries, the agency has granted an expansion of the Infrascanner’s indication to include pediatric cases, too.
The hand-held device uses near-infrared technology to identify signs of a hematoma. It’s held next to a patient’s head to scan four areas on each of the left and right sides of the brain, then compares light absorption at each location to determine whether a serious bruise may be present in any of the areas.
The scanner is approved to detect hematomas that measure at least 3.5 cubic centimeters in volume and are located up to 2.5 centimeters from the surface of the brain. It specifically looks for traumatic supratentorial hematomas, meaning those caused by a traumatic injury and located in the upper region of the brain.
Though not intended to diagnose a brain bleed outright, the device’s readings are meant to help accelerate the amount of time it takes for a physician to examine a patient who presents with a head injury and more accurately determine whether they require additional scans and treatment.
Read more: https://www.fiercebiotech.com/medtech/infrascan-wins-fda-ok-bring-its-hand-held-device-brain-bleed-detection-children