ImpediMed gains FDA Breakthrough Device designation for digital renal failure platform

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ImpediMed, an Australia-based medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to improve patient health, has announced that the Sozo digital health platform has been designated as a Breakthrough Device by the US Food and Drug Administration (FDA) for a proposed indication in renal failure.

Using BIS, the platform aims to provide clinicians with a more precise measure of fluid volume to be removed from a renal failure patient during dialysis.

The current standard-of-care method to measure the accumulation of fluid in kidney failure patients utilises weight scales. These scales cannot account for changes in body composition, however—an ImpediMed press release states—with muscle loss being a common side-effect in end-stage renal disease (ESRD) patients. The potential for Sozo to address this deficiency was paramount in the FDA awarding this Breakthrough Device designation to the digital health platform, the release adds.

“Dry weight assessment and appropriate fluid removal during dialysis remains a significant challenge for nephrologists,” said Mark M Boiskin of the Balboa Nephrology Medical Group and California Institute of Renal Research. “Clinical assessment alone appears to be inadequate in many dialysis patients, especially those with multiple coexisting illnesses including cardiovascular disease and diabetes. Both inadequate fluid removal and excessive fluid removal resulting in hypotension may adversely affect quality of life, increase hospitalisations and increase mortality.

“A device that can quickly and easily be used in the dialysis setting to accurately measure fluid volume is currently not FDA-approved and readily available. Such a device may significantly improve quality of care and improve patient outcomes.”

“We are extremely pleased to be moving forward with the renal opportunity through the FDA Breakthrough Device programme,” said Richard Carreon, managing director and CEO of ImpediMed. “There is a clear need for an innovative device to help clinicians more effectively manage ESRD patients. The mortality rate of these patients remains persistently high, with many dying from fluid-related heart failure.

“We believe Sozo can provide a significant improvement to the dialysis process by better quantifying the volume of fluid needed to be removed. It also allows us to advance the discussions with both potential clinical and commercial partners, with a goal of moving quickly to clinical trials and subsequently to commercialisation.”

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