FDA approves InfraScan’s noninvasive handheld brain hematoma detector
Published on January 17, 2013 at 12:48 AM
InfraScan, a medical device company specializing in brain injury diagnostic products, announced today that it has obtained U.S. Food and Drug Administration approval to market the Infrascanner™ Model 2000, a noninvasive handheld brain hematoma detector.
The Infrascanner™ Model 2000 is a handheld device with a disposable patient interface that uses Near-Infrared (NIR) technology to detect intracranial bleeding, identifying those patients who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
"FDA approval in the U.S. allows InfraScan to offer an industry first, powerful tool for use by civilian and military medical professionals to quickly triage head trauma patients," said Baruch Ben Dor, President and CEO of InfraScan, Inc. "Shortening the time to treatment through effective detection of intracranial bleeding can mean preserving brain function in a patient and even saving lives."
The Infrascanner™ Model 2000 was developed in partnership with U.S. Navy and Marine Corps. The Model 2000 features upgrades that meet the specifications of the U.S. Marine Corps and is a ruggedized, integrated, user-friendly unit.
"Before the Infrascanner, first responders had to rely on imprecise methods to detect brain bleeds in patients, potentially delaying treatment," said Dr. Joseph Maroon, Professor and Vice Chairman of the Department of Neurological Surgery at the University Of Pittsburgh, team neurosurgeon for the Pittsburgh Steelers, and Medical Advisory Board member of civilian Infrascanner™ distributor, MedLogic, LLC.
"Whether on the field of battle with military medical personnel or on the thousands of playing fields with sports health professionals in professional, amateur or youth sports, the Infrascanner can potentially save lives by quickly detecting life-threatening brain bleeds earlier," added Dr. Maroon.