Flashback Technologies Announces U.S. FDA Clearance For The CipherOx® CRI M1 Compensatory Reserve Index (CRI™) Monitor To Accurately Detect And Trend Acute Blood Loss
LOUISVILLE, Colo., July 26, 2018 /PRNewswire/ -- Flashback Technologies, Inc. has been granted 510(k) clearance by the U.S. FDA for the CipherOx® CRI M1 monitor, a handheld device that noninvasively calculates and displays heart rate, SpO2 and the Compensatory Reserve Index (CRI). CRI is a breakthrough hemodynamic parameter that 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 market. Sales of the M1 will begin in the coming weeks.
Steve Moulton, MD, Co-Founder at Flashback and Director, Trauma and Burn Services at Children's Hospital Colorado, stated "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 US Army to meet their need for noninvasive monitoring of acute blood loss. It is the first in a new FDA category of "adjunctive cardiovascular status indicators" and represents a new vital sign in patient monitoring. CRI provides an indication of an individual patient's ability to compensate for intravascular fluid loss (e.g. blood loss) on a scale ranging from 1 (replete intravascular volume) to 0 (high risk of hemodynamic decompensation). It is a proprietary technology, developed using Flashback's advanced data analytics platform CipherSensor™. To date there are more than 20 published clinical and laboratory studies establishing the effectiveness of CRI in detecting and monitoring 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," commented Greg Grudic, PhD, President and Co-Founder at Flashback.
The CipherOx® CRI M1 displays CRI as a "fuel gauge" that goes down or up, depending on whether the patient continues to lose volume (bleed) or gain volume (active fluid resuscitation). The screen also displays the instantaneous CRI value, a 20-minute trend graph, HR and SpO2 values. The device is battery powered and intended for use in pre-hospital and hospital settings.
Flashback Technologies, Inc. uses the power of data analytics for good, by applying their patented CipherSensor™ technology to develop powerful precision monitors for the medical marketplace. Flashback is located in Louisville, CO, and collaborates closely 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, Aurora, CO.
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SOURCE Flashback Technologies, Inc.