FDA OKs handheld device to detect skull bleeding

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The FDA has allowed marketing of a handheld device intended to aid in the detection of intracranial hematomas using near-infrared spectroscopy. The device is expected to help determine if a CT study is needed in patients with critical head injuries.

According to the Centers for Disease Control and Prevention, each year about 1.7 million people in the U.S. experience a traumatic brain injury.

The Infrascanner Model 1000 uses a scanner that directs near-infrared light, a wavelength of light that can penetrate tissue and bone, into the skull. Blood from intracranial hematomas absorbs the light differently than other areas of the brain. The scanner detects differences in light absorption (optical density) and transmits the information wirelessly to a display on a handheld computer.

By comparing the optical density from a series of scans of specific areas on both sides of the skull, a healthcare provider can use the information provided by the device, in conjunction with other clinical information, to determine the likelihood of an intracranial hematoma and the need for further diagnostic procedures, such as a CT study.

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 agency granted the 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 said.

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