FDA Designates ImpediMed’s Sozo for Renal Failure a Breakthrough Device
Brisbane, Australia-based ImpediMed’s Sozo bioimpedance spectroscopy platform has received the FDA’s Breakthrough Device designation.
The new designation is for use of the device in renal patient population to provide an exact measure of the fluid volume to remove during a dialysis session.
The Sozo platform has been designed to address a deficiency in the current standard of care, which uses weight scales are used to determine the accumulation of fluid. The scales cannot account for changes in body composition, such as the muscle loss frequently seen in end-stage renal disease patients.