InfraScanner is now the only hand-held device cleared by the FDA to detect 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”.
InfraScan extends its gratitude to Children's Hospital of Philadelphia (CHOP), Boston Children's Hospital, Colorado Children's Hospital, The Division of Global Neurosurgery and Neurology at Duke University, Baylor College of Medicine and Pittsburgh Children's Hospital for their dedicated research which helped lead to this announcement. InfraScan also wishes to recognize the Pennsylvania Pediatric Medical Device Consortium (ppdc.research.chop.edu) and the Childress Institute for Pediatric Trauma (saveinjuredkids.org) for their invaluable support during this groundbreaking research.
InfraScan has over 1,000 devices deployed in the US and internationally, including with some of the world's leading adult and pediatric Trauma experts. InfraScan also licensed a variety of patents that apply to hemorrhagic and ischemic stroke detection and brain hemorrhage monitoring.
About InfraScan, Inc.
InfraScan, Inc. is a medical device company that focuses on developing, commercializing and distributing portable brain scanners for Traumatic Brain Injuries (TBI) based on near-infrared (NIR) technologies. The company has received funding from the U.S. Army Medical Materiel Development Activity, U.S. Marine Corps, Office of Naval Research, BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, Ben Franklin Technology Partners of Southeastern Pennsylvania, and from the Philadelphia Industrial Development Corporation. For more information visit http://www.infrascanner.com and follow us @infrascanner.