Flashback secures FDA approval for health monitor

LOUISVILLE — Flashback Technologies Inc., which develops analytical devices for health monitoring, has received approval from the U.S. Food and Drug Administration for its CipherOx CRI M1 monitor, a handheld device that noninvasively calculates and displays heart rate, blood-oxygen levels and other factors.

The device also provides real-time, noninvasive indication of changes in intravascular volume relative to the individual patient’s response to blood loss.

The M1 is Flashback’s first commercial CRI product to reach the market, with sales set to begin in the coming weeks.

Steve Moulton, Flashback co-founder and director of trauma and burn services at Children’s Hospital Colorado, said in a prepared statement that, “The M1 is a cutting edge medical device designed to detect and continuously monitor acute blood loss in the field and in hospital settings.  It will enable healthcare providers to identify and respond to the needs of acutely bleeding patients much earlier, when their physiology is less complex and more likely to respond to therapy.”

CRI was initially developed with support from the U.S. Army to meet the need for noninvasive monitoring of acute blood loss.

“We are excited to put CRI technology in the hands of medics and physicians, where it will really make a difference by helping to detect and manage patients experiencing blood loss,” said Greg Grudic, Flashback president and co-founder.

Flashback is headquartered  in Louisville and collaborates with leading medical research institutions, including various groups within the U.S. Department of Defense, Children’s Hospital Colorado and the University of Colorado, Anschutz Medical Campus in Aurora.