FDA Approves Handheld Intracranial Hematoma Detector

December 19, 2011

The U.S. Food and Drug Administration has approved the first handheld device to detect intracranial hematomas - bleeding in the skull - which the agency says can help determine if patients with critical injuries need an immediate CT scan.

The U.S. Food and Drug Administration has approved the first handheld device to detect intracranial hematomas - bleeding in the skull -  which the agency says can help determine if patients with critical injuries need an immediate CT scan.

The Infrascanner Model 1000, made by InfraScan Inc. of Philadelphia, Pa., uses near-infrared light, a wavelength of light that can penetrate tissue and bone. 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 clinician 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 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,” Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, said in a statement.

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 detected nearly 75 percent of the hematomas detected by CT scan. When CT scans detected no hematoma, the Infrascanner also detected no hematoma 82 percent of the time. The Infrascanner Model 1000, however, is not a substitute for a CT scan, the FDA says.

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.

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