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| [January 16, 2013] |
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InfraScan Receives FDA Approval of Next Generation, Noninvasive Handheld Brain Hematoma Detector
PHILADELPHIA --(Business Wire)--
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.
The Infrascanner™ Model 2000 is available to US civilian customers
through MedLogic (www.med-logic.us),
the exclusive civilian market distributor of the Infrascanner™, and to
US military customers through ADS Medical (www.adsinc.com),
the exclusive military market distributor of the Infrascanner™. To
contact a distributor in other countries, visit http://www.infrascanner.com/contact-us/distributor-directory/.
About Traumatic Brain Injury
An estimated 1.5 million individuals seek medical treatment for head
trauma in the U.S. each year, and a total of 10 million individuals seek
head trauma treatment annually worldwide. Intracranial hematomas
resulting from a traumatic brain injury are life-threatening and have
been reported to occur as the primary injury in 40% of patients with
severe head injury.
Successful treatment often relies upon timely diagnosis and intervention
prior to neurological deterioration. The early identification of a brain
hematoma can play a significant role in facilitating transportation of
critically injured patients to facilities, which can both verify
Infrascanner's early diagnosis and offer surgical intervention.
About InfraScan
InfraScan, Inc. is a medical device company that focuses on developing,
commercializing, and distributing hand-held diagnostic devices for head
injury and stroke assessment based on near infrared (NIR) technology.
The company has received funding from the U.S. Marine Corps, the Office
of Naval Research, BioAdvance, the Biotechnology Greenhouse of
Southeastern Pennsylvania, the Ben Franklin Technology Partners of
Southeastern Pennsylvania, and from the Philadelphia Industrial
Development Corporation.
For more information about the Infrascanner Model 2000, visit www.infrascanner.com.
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