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ImpediMed - FDA Grants Breakthrough Device Designation for Renal Failure


ImpediMed Limited (ASX.IPD) is pleased to announce SOZO has received FDA Breakthrough Device Designation for a proposed indication in a renal patient population.

ImpediMed intends to use its well-established SOZO bioimpedance spectroscopy (BIS) platform to provide an exact measure of fluid volume to remove during a dialysis session. The current process, utilising weight scales to determine accumulation of fluid, has significant deficiencies. The scales cannot account for changes in body composition, with muscle loss being prevalent in end-stage renal disease patients. The potential for SOZO to address this deficiency was paramount in meeting the criteria for Breakthrough Designation.

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