InfraScan has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its handheld Infrascanner Model 1000 near-infrared spectroscopy device, designed to detect bleeding in the skull.
The Infrascanner Model 1000 directs near-infrared light, which can penetrate tissue and bone, into the skull. Blood from intracranial hematomas absorbs the light differently than other parts of the brain; the scanner can detect these differences and transmits the information wirelessly to a display on a handheld computer.
The FDA granted clearance for the system based on a review of data comparing results from 383 CT scans of adult subjects with Infrascanner scan results. Infrascanner was able to detect approximately 75% of the hematomas detected by CT; when CT scans detected no hematoma, the Infrascanner detected no hematoma 82% of the time.
The company emphasized that the Infrascanner Model 1000 is not intended to replace a CT scan. In announcing the clearance, the FDA said the device could be used to determine if further diagnostic tests such as CT are needed.
In its clearance, the FDA specified that the Infrascanner Model 1000 is 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 FDA said.
