Portable brain scanner wins FDA approval
- Created on Monday, 09 January 2012 20:39
- Last Updated on 17.05.2012
- Published Date
On those rare occasions when an athlete becomes unresponsive, the clock starts ticking. The decision to airlift to a trauma center or transport to the local hospital can mean the difference between life and death.
In the case of brain injuries, medical personnel make note of the "golden hour," the 60 minutes after an injury occurs when treatment is so critical.
InfraScanTM, a Philadelphia-based company, now has FDA approval to market their portable brain scanner that can help quickly determine the nature of a brain injury and who needs advanced medical care (see video).
The device, called the Infrascanner Model 1000, is the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.
The unit can also help emergency room physicians determine who needs a CT scan and who can avoid the radiation-based imaging.
Intracranial hematomas occur when blood from a ruptured blood vessel collects within the brain or between the skull and the brain. As blood expands within the brain or in the narrow space between the brain and the skull, the brain becomes compressed. This can produce symptoms such as headaches, vomiting, dizziness, lethargy, weakness in the arm or leg on one side of the body, seizures, or unconsciousness. An intracranial hematoma can be life-threatening if it is not treated immediately.
Funded by the Office of Naval Research (ONR), the Infrascanner was originally designed for soldiers deployed in remote locations. It has been used in Europe for several years.
“Naval warfighters, on ship or land, may be a great distance away from any definitive medical care,” said Dr. Michael Given, ONR’s program manager for expeditionary medicine, combat casualty care. “So something like this could be very useful, almost essential.”
The device is designed for quick and easy use.
“You can do the whole scan in a minute or so,” said Given. “We tried to make it simple. Just a red-green lighted spot kind of display. So red, you’re in trouble; green, everything’s great. There are three sizes of red dots so you can tell if the bleeding is progressing. Simple and effective.”
Helping athletes avoid unnecessary CT scans
An important issue facing emergency room physicians when evaluating concussed athletes is determining who needs a CT scan. Typically, CT scans do not diagnose concussions, but are invaluable for detecting hematomas and skull fractures, both of which are rare occurrences related to sports concussions. CT scans add to the athlete's overall lifetime accumulation of radiation. The Infrascanner helps medical professionals determine who is most at risk for a hematoma, and who can avoid radiation-related imaging.
“While patients with suspected brain injuries routinely receive a CT scan, this portable device offers emergency room physicians a non-invasive mechanism to aid in assessing whether an immediate CT scan is needed,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.
The Infrascanner detects near-infrared light that penetrates into the skull. Pooled blood from hematomas absorbs that light differently from oxygenated blood circulating in blood vessels, and the device detects that difference.
Given said the greatest danger from hematomas is that they are sometimes not discovered until too late.
“If it goes undiagnosed and things look normal, and maybe a day later, you die of cerebral hemorrhage,” he said. “And it could be because people have a headache and then take aspirin—that interferes with the coagulation cascade, so they start bleeding even more.
“If you don’t know it’s going on, that’s the danger,” he added. “So that’s where this device fits in.”
The Infrascanner is not designed to replace a CT scan. Each unit will cost approximately $15,000.
Source: Naval technology could be a lifesaver - Office of Naval Research
FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull - FDA
Questions/comments? Contact Jean Rickerson at This email address is being protected from spambots. You need JavaScript enabled to view it.
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