FMCNA announces FDA clearance for automated PD machine
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Fresenius Medical Care North America announced the FDA has awarded 510(k) clearance to its VersiPD cycler.
“The clearance of VersiPD is another important step in our effort to make home therapies easier for patients and more efficient for clinicians,” Joe Turk, president of the renal therapies group of FMCNA, said in a press release. “We have listened closely to what patients and clinicians want in a home dialysis experience and have brought those ideas into the heart of this innovative system.”
FMCNA said the VersiPD is an automated peritoneal dialysis device that is simple, quiet, portable and advanced. The device is designed to improve health equity by making home therapy a more feasible option for a broader population of dialysis patients.
“VersiPD will allow patients to enjoy restful sleep through its almost silent operation, fewer disruptive alarms, and night mode,” according to the release. “The cycler has the capability of more personalized prescription programming to meet the individual needs of a broad range of patients” and offers an intuitively designed touchscreen, as well as embedded videos with audio guidance to assist patients step-by- step through setup and treatment, according to the company.
“We believe that our new VersiPD will empower more patients to reclaim their freedom and independence, while further enabling care teams to better support patients and intervene more quickly when necessary,” Mike Anger, MD, chief medical officer for the renal therapies group of FMCNA, said. “We know most patients can be successful dialyzing at home with the right technology and support, and this new cycler is an important milestone in our journey to truly transform dialysis care.”
VersiPD is supported by the Kinexus Therapy Management Platform, a connected health system aimed at improving patient outcomes and nurse productivity through remote therapy monitoring and programming capabilities, according to the company.
FMCNA said VersiPD will begin a limited rollout in 2022, with more widespread availability planned in 2023 and beyond.
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