Predictive data analytics company Flashback Technologies said today it won FDA de novo clearance for devices using its Compensatory Reserve Index algorithm, now cleared as an adjunctive cardiovascular status indicator.
The Boulder, Colo.-based company’s CRI product is designed to provide noninvasive, real-time measurement of a patient’s ability to tolerate changes in intravascular volume, such as blood loss.
“This clearance is an important step for an emerging class of precision algorithms and a significant accomplishment for Flashback, which has developed CRI over the past several years primarily with grant funding from the U.S. Department of Defense. We are enthusiastic about the FDA’s clearance of CRI and the creation of a predicate, against which other CRI based products can be cleared. Flashback’s commercial launch of its first CRI product is expected in 2017. We look forward to getting CRI into the hands of healthcare providers to help them improve the care of their patients,” prez & CEO Gordon Van Dusen said in a press release.
Flashback Tech said the CRI product works through the use of continuous photoplethysmogram signals which capture the pulsatile component of the cardiac cycle to estimate CRI values, which are displayed as a “fuel gauge” with a trend line.
“All of the hard work and effort that went into developing and validating CRI has led to this important milestone. Clinicians and their patients will benefit from CRI’s use as an adjunctive cardiovascular indicator of acute changes in blood volume. We believe the Compensatory Reserve Index will have a tremendous impact on the speed and accuracy of monitoring and managing patients who suffer acute blood loss,” co-founder Dr. Steven Moulton said in prepared remarks.