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FDA approves intracranial bleeding detector

Infrascanner 1000 is a handheld device for detection of intracranial hematomas


The Food and Drug Administration has issued clearance to InfraScan, Inc. for marketing the new Infrascanner 1000.

The Infrascanner 1000 is a handheld device for detection of life-threatening bleeding — intracranial hematomas — in the skull. 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.

Photo InfraScan
Photo InfraScan

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 percent sensitivity and 90.7 percent 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.
EMTs 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.

The revolutionary tool could see quick deployment. According to Dr. Baruch Ben Dor, president of Philadelphia’s InfraScan, which makes the Infrascanner, a plan is already in place through ONR to move the system to field evaluation with the Marine Corps Systems Command.

The Marines are testing a "ruggedized" version of the device that meets military standards for resistance to water, sand, corrosion by salt spray and more.
For more information and to follow further developments, check out http://www.infrascanner.com/.

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