The first handheld device intended to aid in the detection of life-threatening bleeding in the skull has been approved by the FDA. The device, called the Infrascanner Model 1000, can help health care providers identify patients with critical head injuries who need an immediate brain imaging study. Bleeding within the skull, called an intracranial hematoma, occurs when blood from a ruptured vein or artery collects within the brain or between the skull and the brain. As the escaped blood expands, the brain itself is compressed, producing symptoms such as headaches, vomiting, dizziness, lethargy, weakness in a limb or 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 US experience a traumatic brain injury. The Infrascanner Model 1000, which is made by InfraScan Inc. of Philadelphia, uses a near-IR scanner, which can nondestructively penetrate the skull through tissue and bone. Blood from intracranial hematomas absorbs the light differently than other areas of the brain. The scanner detects differences in light absorption and transmits the information wirelessly to a display on a handheld computer. By comparing the recorded optical densities from a series of scans of specific areas on both sides of the skull, a trained health care 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 computed tomography (CT) scan. “While patients with suspected brain injuries routinely receive a CT scan, this portable device offers emergency room physicians a noninvasive mechanism to aid in assessing whether an immediate CT scan is needed,” said Christy Foreman, director of the Office of Device Evaluation at the 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. For more information, visit: www.infrascanner.com