Baxter Wins FDA 510(k) Clearance for Peritoneal Dialysis System

Baxter International said Tuesday that it will launch its AMIA automated peritoneal dialysis system in the U.S. before the end of the year, following the receipt of FDA 510(k) clearance.

The device — intended for use with end-stage renal disease patients — contains the Sharesource web-based remote connectivity platform, allowing physicians to remotely access their home patients’ historical treatment data and deliver individual prescriptions.

The system also features animated graphics and automated step-by-step instructions to help increase the efficiency of home therapy training.

Baxter plans to launch the system in the U.S. in 2015. — Michael Cipriano