www.fdanews.com/articles/207560-fresenius-medical-care-gets-fda-clearance-for-its-versipd-peritoneal-dialysis-system
Fresenius Medical Care Gets FDA Clearance for its VersiPD Peritoneal Dialysis System
April 27, 2022
Fresenius Medical Care has received 510(k) clearance from the FDA for its VersiPD Cycler, a portable peritoneal dialysis system.
The cart-mounted system, which features a large touchscreen and embedded videos with audio guidance, is designed to make home therapy a more feasible option for dialysis patients.
The device includes a night mode that allows patients to “enjoy restful sleep through its almost silent operation,” the company said.
A limited U.S. rollout of VersiPD will begin this year, with wider availability planned in 2023.