Nightly Home Hemodialysis Gains First FDA Clearance
This article was originally published in The Gray Sheet
NxStage’s System One has received an expanded indication to treat patients overnight at home, which the company says improves quality of life.
You may also be interested in...
Teleflex buys Vidacare Corp. for $262.5 million. Integra LifeSciences acquires Covidien’s Confluent Surgical product line, including the DuraSeal products, for $235 million, plus up to $30 million in milestone payments. W.L. Gore ordered to pay more than $850 million to C.R. Bard to partially resolve a long-running patent dispute. More news.
Deal builds on Baxter’s home peritoneal dialysis-focused business by adding a suite of products for hemodialysis in the clinic, including Gambro’s Artis and AK 96 systems.
An April 15 FDA guidance tells makers of nocturnal home hemodialysis systems what sorts of clinical trials they should perform to smooth the FDA pre-market clearance process