InfraScan wins FDA OK for its hand-held brain bleed detector for children

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.

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With the new green light—which brings the Infrascanner to patients as young as 2 years old—it’s now “the only hand-held device in the U.S. healthcare market which is cleared for use in the pediatric population to aid in the diagnosis of patients with a potential traumatic brain hemorrhage,” InfraScan CEO Baruch Ben Dor, Ph.D., said in a statement.

The FDA clearance followed multiple studies that demonstrated the scanner’s use in spotting signs of hematoma in young patients.

In one of the studies, published in March 2021, researchers compared the results of the Infrascanner’s analyses to those of traditional CT scans in 344 patients under the age of 18 who were admitted to an emergency department with head trauma.

In the comparison, the Infrascanner spotted 13 of the 16 hematomas that fell within the size and location parameters and were detected by a CT scan. That added up to a sensitivity rate of 81%, while the device also offered specificity of just over 67%. The researchers also studied the scanner’s ability to detect hematomas of any size and depth, which were found in a total of 36 patients’ CT scans. The Infrascanner identified 21 of these, for a sensitivity rate of about 58%.

Those results led the researchers to conclude that “the hand-held brain scanner can non-invasively detect a subset of intracranial hematomas in children and may serve an adjunctive role to head-injury neuroimaging decision rules that predict the risk of clinically significant intracranial pathology after head trauma.”

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The Infrascanner was first approved by the FDA in 2011. InfraScan quickly followed up that regulatory win with another in 2013, for a second-generation version of the device that had been developed in partnership with the U.S. Navy and Marine Corps to be more “rugged” and user-friendly.

Since the scanner’s launch, the Philadelphia-based company says it has distributed more than 1,000 Infrascanners in the U.S. and abroad.