FDA approves hand-held intracranial bleeding detector

On December 13th, 2011 the Food and Drug Administration issued clearance to InfraScan, Inc.  for marketing the new Infrascanner 1000. The Infrascanner 1000 is a handheld device for detection of life-threatening bleeding in the skull, called intracranial hematomas. It uses near-infrared (NIR) technology to screen patients for intracranial bleeding.

NIR light can penetrate tissue and bone several centimeters deep into the skull. The scanner detects differences in light absorption and transmits the information wirelessly to an easy to read visual display. In only 2-3 minutes it can identify those who would most benefit from an immediate CT scan and neurosurgical intervention. It can be used as a simple extension of the routine neurological examination.

The Infracanner 1000 can detect hematomas larger than 3.5 cm, up to 3.5cm from the skin surface. It does this with an accuracy of 88% sensitivity and 90.7% specificity. A 431 patient, multi-center clinical trial showed that the Infrascanner was better than a physical examination alone, in identifying patients at high risk of intracranial bleeding.

The FDA’s Christy Foreman, Director Of Device Evaluation said “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.”

The Infrascanner is not a replacement for a CT scan, but it may well be the next best thing. That could make it the next must have diagnostic device for EMS. EMT’s and Paramedics could see who really needs a neurosurgeon right now. It would help them make selecting the most appropriate hospital transport destination a life saving decision.

That could be very significant because each year about 1.7 million people in the United States experience a traumatic brain injury. For more information and to follow further developments, check out http://www.infrascanner.com/.


About Dan White

I'm a retired Paramedic and EMS Instructor with 35 years EMS and emergency medical product experience. I love canoes, cars and EMS. I have written a lot about EMS Technology on the Paramedic Blog, the Insights on Innovation column for EMS1.com, on AmbulanceWorld.com and Multibriefs.com. I can be reached directly at 573-240-0002.
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