InfraScan Announces FDA Clearance of the First Hand-Held Diagnostic Device for Traumatic Brain Hemorrhage in Children

InfraScan, a medical device firm specializing in traumatic brain injury diagnostic products, announced a newly expanded FDA indication today.

The expanded indication includes the use of Infrascanner for the detection of traumatic supratentorial hematomas in adults, and now pediatric patients aged 2 years and older.

“We are excited to announce the FDA has granted clearance for the use of the Infrascanner technology in the pediatric population aged 2 years and older. Infrascanner is 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”, said Baruch Ben Dor, PhD, president and CEO of InfraScan. “The Infrascanner is a cutting-edge technology that can now be used as an additional asset for clinicians as they follow the PECARN guidelines in their moderate risk pediatric patient’s evaluations”.

Read the full article here.