Flashback Technologies Receives FDA Clearance to Market Medical Device With CRI Algorithm

Flashback Technologies Inc., a privately held predictive data analytics technology company, has been granted a de novo request by the U.S. Food and Drug Administration (FDA) to market a device with its algorithmic product, the Compensatory Reserve Index (CRI). CRI is a hemodynamic parameter that provides real-time noninvasive measurement of a patient’s ability to tolerate changes in intravascular volume, such as blood loss.

The FDA granted CRI a new product device classification known as an “adjunctive cardiovascular status indicator.”
 
“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,” said Gordon Van Dusen, president and CEO at Flashback. “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.”
 
CRI provides an indication of an individual patient’s ability to compensate for intravascular fluid loss (e.g. blood loss). The algorithm uses continuous PPG (photoplethysmogram) signals, which capture the pulsatile component of the cardiac cycle to estimate CRI values. These are displayed as a simple-to-interpret “fuel gauge” with a trend line. CRI is an adjunctive cardiovascular indicator for areas of care that place a high priority on monitoring hemodynamic status and fluid management, enabling the potential for earlier life-saving interventions and reducing healthcare costs.
 
“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,” said Dr. Steven Moulton, director of pediatric trauma and burn services at Children’s Hospital Colorado and co-founder at Flashback. “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.”
 
Flashback Technologies is a predictive data analytics technology company whose feature selection and machine learning platform, CipherSensor, is being applied to noninvasive vital sign waveform data to develop products that bring precision monitoring to the medical marketplace. Flashback’s near-term focus is developing and commercializing algorithms that enable real-time individual-specific monitoring and management of critically ill and injured patients. The company’s first product, the Compensatory Reserve Index (CRI), is the first algorithm to be classified by the FDA as an adjunctive cardiovascular status indicator. It was developed with support from the U.S. Army for noninvasive monitoring of acute blood loss. Flashback is located in Boulder, Colo., and collaborates closely with several leading medical research institutions including various groups within the U.S. Department of Defense and the University of Colorado, Anschutz Medical Campus (Aurora, Colo.).