First brain bleed detection device wins FDA nod | Regulatory Roundup

December 15, 2011 by MassDevice staff

Infrascan's handheld scanner landed FDA de novo approval to help first responders detect brain bleeds in patients who have undergone a traumatic head injury.

The Infrascanner Model 1000 uses near-infrared imaging to detect bleeds at an injury site within the "golden hour," the period following head trauma when pre-hospital analysis is critical.

"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, of the FDA's Center for Devices & Radiological Health, said in prepared remarks.

Sign up to get our free newsletters delivered right to your inbox

The federal watchdog agency approved the Infrascanner through the "de novo" classification process, a pathway designed for low-risk medical devices that can't be compared to devices currently on the market.

In a 383-patient study, the Philadelphia-based company's handheld scanner detected nearly 75 percent of brain bleeds detected by a computed tomography scan. When CT scans detected no hematoma, neither did the Infrascanner 82 percent of the time.

The federal watchdog agency stressed that the Infrascanner Model 1000 is not a replacement for a standard CT scan.

Permalink