Baxter wins FDA nod for Amia dialysis device

Baxter (NYSE:BAX) said yesterday that it won 510(k) clearance from the FDA for its Amia automated peritoneal dialysis system, saying it plans to launch the device in the U.S. this year. The Amia device, which uses Deerfield Park, Ill.-based Baxter’s ShareSource web-based remote connection, is designed for home use by patients with end-stage renal disease. Baxter claimed Amia as the sole U.S.-cleared device with voice guidance, touchscreen controls and ShareSource 2-way connectivity. “PD is an important treatment option for many patients with kidney disease seeking home-based therapy,” Dr. Jaime Uribarri, of New York’s Mt. Sinai Hospital, said in prepared remarks. “We welcome new technology that allows patients to start and administer their physician-prescribed PD therapy at home.” “Enabling patients to actively work with their healthcare providers to initiate and confidently manage their dialysis therapy is the ultimate goal in the development of Amia withShareSource,” added Baxter renal therapeutic area lead Dr. Bruce Culleton. “Baxter’s focus is to understand and support access to the best renal replacement options for all patients, and then bring technology like Amia andShareSource to healthcare providers so they can help their patients achieve their best possible outcomes.” The post Baxter wins FDA nod for Amia dialysis device appeared first on MassDevice.
Source: Mass Device - Category: Medical Equipment Authors: Tags: Dialysis Food & Drug Administration (FDA) Regulatory/Compliance Baxter International Source Type: news