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”.
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