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FDA Permits Marketing of the First Hand-Held Device To Aid in the Detection of Bleeding In The Skull
Date:12/13/2011

edures, such as a computed tomography (CT) scan.  

"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 FDA reviewed data for the Infrascanner Model 1000 through the "de novo" classification process, a regulatory pathway for some low to moderate risk medical devices that are not comparable to a legally marketed device.

The FDA granted the de novo petition for the Infrascanner Model 1000 based on a review of data comparing results from 383 CT scans of adult subjects with Infrascanner scan results. The Infrascanner was able to detect nearly 75 percent of the hematomas detected by CT scan. When CT scans detected no hematoma, the Infrascanner detected no hematoma 82 percent of the time. The Infrascanner Model 1000, however, is not a substitute for a CT scan.

The FDA is specifying special controls in an accompanying regulation classifying the Infrascanner Model 1000 as a Class II device with special controls. The special controls provide information about specific risks that must be addressed by other manufacturers who may wish to market a similar device.

The Infrascanner Model 1000 is manufactured by InfraScan Inc. of Philadelphia.

For more information:

FDA: Medical Devices
http://www.fda.gov/MedicalDevices/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply
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SOURCE U.S. Food and Drug Administration
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