Infrascan gets FDA's OK for hematoma detector

The FDA has allowed the marketing of the first hand-held device to help detect intracranial hematomas using near-infrared spectroscopy. Infrascan, which was named one of FierceMedicalDevices 5 device/diagnostics companies to watch in October, makes the device, called the Infrascanner Model 1000.

The Infrascanner uses a scanner that directs near-infrared light--which 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 and transmits the data wirelessly to a display on a hand-held computer.

By comparing the optical density from a series of scans on both sides of the skull, a healthcare provider can use the data with other clinical information to determine the likelihood of an intracranial hematoma and the need for further diagnostic procedures, such as a CT scan.

It is essential that doctors identify hematoma during the first hour after head trauma--the so-called "golden hour"--to determine what treatment is necessary to prevent further damage to the brain, CEO Baruch Ben Dor (photo) told FMD back in October. The Infrascanner can help in these instances and can be used in a number of settings, including hospital emergency rooms and ICU units. It could potentially be used in emergency medical vehicles, developing world medical clinics and war and disaster zones, the company notes on its website.

The CDC estimates roughly 1.7 million people in the U.S. each year experience a traumatic brain injury, the FDA says in a statement. 

- see the FDA's release

Special Report: Infrascan - 5 device/diagnostic companies to watch