FDA Approves New Handheld Brain Haematoma Detector

In short

InfraScan, a medical device company specializing in brain injury diagnostic products, announced today that it has obtained U.S. FDA approval to market the Infrascanner™ Model 2000, a noninvasive handheld brain haematoma detector.


We first came across Infrascan and its original Infrascanner™ 1000 device back in November 2011 when it gained FDA approval. That model was the first hand-held device intended to aid in the detection of life-threatening intracranial haematomas, using near-infrared spectroscopy. What it did was help health care providers identify which head trauma patients require immediate CT scan, thereby speeding their access to treatment, especially important in remote locations or where healthcare systems lack the funding for expensive technology.

The Infrascanner™ Model 2000 was developed in partnership with U.S. Navy and Marine Corps and features upgrades that meet their specifications, being more rugged, integrated and user-friendly.

Company comments

“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.”

Physician comments 

“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.

Source: Infrascan, Inc., Business Wire