Flashback Technologies Announces U.S. FDA De Novo Clearance to Market the First Medical Device Containing Its Compensatory Reserve Index (CRI™) Algorithm

By: Guest Author | Posted on: Apr 04, 2017

This article was originally published on yahoo.com. View the original article by clicking here

 Compensatory Reserve Index, medical technology, health care technology

Flashback Technologies, Inc. (“Flashback” or the “Company”), a privately held predictive data analytics technology company, announced today that it has been granted a de novo request by the U.S. FDA to market the first device with its algorithmic product, the Compensatory Reserve Index (CRI™). CRI is a breakthrough 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.”

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“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,” commented 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.”


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