![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Fresenius Medical Care Gets FDA Clearance for its VersiPD Peritoneal Dialysis System
Fresenius Medical Care Gets FDA Clearance for its VersiPD Peritoneal Dialysis System
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.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct