Three years following EU clearance, Infrascan out of Philly, PA finally received FDA approval of its Infrascanner Model 1000 device for detecting intracranial hematomas.
The device uses near infrared light to penetrate the skull and detect intracranial blood collections. By testing different regions on the skull, ER docs can quickly decide whether a follow up CT scan is needed, saving critical time when it really counts.
From the product page:
Infrascanner™ is a hand-held, non-invasive, near-infrared (NIR) based mobile imaging device to detect brain hematoma at the site of injury within the “golden hour”. This refers to the period following head trauma when pre-hospital analysis is needed to rapidly assess the neurological condition of a victim.
The InfraScanner™ can be a practical solution to the problem of early identification of intracranial hematomas because of the unique light-absorbing properties of hemoglobin and the non-invasive, non-ionizing nature of NIR technology. The basic method for Hematoma detection is based on the differential light absorption of the injured vs. the non-injured part of brain. Under normal circumstances, the brain’s absorption should be symmetrical. When additional underlying extra vascular blood is present due to internal bleeding, there is a greater local concentration of hemoglobin and consequently the absorbance of the light is greater while the reflected component is commensurately less. This differential can be detected via sources and detectors placed on symmetrical lobes of the skull. The science of diffused optical tomography used by the Infrascanner™ enables the conversion of light differential data into interpretative scientific results. The Infrascanner™ unit is a small, portable handheld device based on a PDA platform with wireless detector probes.
Product page: Infrascanner…
Press release: FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
Flashbacks: Infrascanner, an Intracranial Hematoma Detector, Goes on Sale in Europe; Quick, Cheap & Easy Bedside Diagnosis of Brain Injury
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