FDA grants breakthrough device designation to digital fluid management tool
Click Here to Manage Email Alerts
The FDA granted breakthrough device designation to ImpediMed Limited’s digital health platform for a proposed indication in kidney failure; the device uses bioimpedance spectroscopy to assess fluid status in patients on dialysis.
“We are extremely pleased to be moving forward with the renal opportunity through the FDA Breakthrough Device Program. There is a clear need for an innovative device to help clinicians more effectively manage end-stage renal disease patients,” Richard Carreon, managing director and CEO of ImpediMed, said in a company press release. “ ... We believe SOZO can provide a significant improvement to the dialysis process by better quantifying the volume of fluid needed to be removed.”
According to the release, the SOZO Digital Health Platform addresses important limitations in how the accumulation of fluid is typically measured.
“The current standard-of-care method to measure the accumulation of fluid in kidney failure patients utilizes weight scales,” according to the release. “These scales cannot account for changes in body composition, with muscle loss being a common side effect of end-stage renal disease patients. The potential for SOZO to address this deficiency was paramount in the FDA awarding its breakthrough designation to the SOZO Digital Health Platform.”
According to the release, the bioimpedance spectroscopy device is noninvasive and, after measuring 256 unique data points, provides results in less than 30 seconds; these results can then be shared across health systems.
“Dry weight assessment and appropriate fluid removal during dialysis remains a significant challenge for nephrologists. Clinical assessment alone appears to be inadequate in many dialysis patients, especially those with multiple coexisting illnesses including cardiovascular disease and diabetes,” Mark M. Boiskin, MD FACP, of the Balboa Nephrology Medical Group and California Institute of Renal Research, said in the release. “Both inadequate fluid removal and excessive fluid removal resulting in hypotension may adversely affect quality of life, increase hospitalizations 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.”
Collapse
Read more about
Click Here to Manage Email Alerts