Baxter wins Health Canada nod for Amia peritoneal dialysis system

Baxter (NYSE:BAX) said today that it won a nod north of the border for its Amia automated peritoneal dialysis system. The Health Canada approval makes Amia the 1st automated peritoneal dialysis device cleared in the U.S. and Canada that includes voice guidance, touchscreen control and 2-way telemedicine features, Deerfield Park, Ill.-based Baxter said. “As a leader in home dialysis, Baxter is committed to understanding patients’ and clinicians’ needs, so we can provide innovative therapy options that are designed to support access to care where and when it’s needed,” Baxter Canada head Stephen Thompson said in prepared remarks. “Baxter’s Amia with Sharesource system is uniquely designed to help more patients self-administer home PD therapy and allow healthcare providers the ability to remotely manage their patients’ care.” Baxter said it plans to start a pilot launch of the Amia device in Canada late this year. The device won 510(k) clearance from the FDA in October 2015. Earlier this month, Baxter CEO Jose Almeida said the company is getting out of the home hemodialysis business, ceding the field to market leader NxStage Medical (NSDQ:NXTM). The post Baxter wins Health Canada nod for Amia peritoneal dialysis system appeared first on MassDevice.
Source: Mass Device - Category: Medical Equipment Authors: Tags: Dialysis Regulatory/Compliance Baxter International Health Canada Source Type: news