First brain bleed detection device wins FDA nod | Regulatory Roundup

Infrascanner

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.

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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.

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