The US Food and Drug Administration (FDA) has granted De Novo Clearance to Flashback Technologies to market the first device with its algorithmic product, the Compensatory Reserve Index (CRI).
CRI offers an indication of an individual patient’s ability to compensate for intravascular fluid loss. The algorithm utilize continuous PPG (photoplethysmogram) signals, which capture the pulsatile component of the cardiac cycle to predict CRI values.
Flashback Technologies said 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.
It is the first algorithm to be classified by the FDA as an adjunctive cardiovascular status indicator. It was developed with support from the US Army, for noninvasive monitoring of acute blood loss.
Flashback president and CEO Gordon Van Dusen said: “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 US 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.”