Fresenius Medical Care announced today it received FDA 510(k) clearance for its next-generation Versi PD cycler system.
The company designed the portable automated peritoneal dialysis (APD) system (from Fresenius Medical Care North America) as a light, simple, quiet, portable and advanced platform for improving health equity by making home therapy a more feasible option for a broader population of dialysis patients.
According to a news release, FDA clearance makes the Versi PD cycler system the lightest, smallest and quietest dialysis cycler in the U.S.
The company developed VersiPD to allow patients to enjoy restful sleep through its near-silent operation, with fewer disruptive alarms and a night mode option. The cycler also has the capability of more personalized prescription programming to meet the individual needs of a wide range of patients.
VersiPD includes a touchscreen and embedded videos with audio guidance to assist patients through each step of setup and treatment.
Fresenius plans a limited rollout for VersiPD in 2022 with more widespread availability expected in 2023 and beyond.
“The clearance of VersiPD is another important step in our effort to make home therapies easier for patients and more efficient for clinicians,” Fresenius Medical Care North America’s Renal Therapies Group President Joe Turk said in the 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.”