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J.P. Morgan Healthcare Conference In Brief

This article was originally published in The Gray Sheet

Executive Summary

NxStage Medical: The Lawrenceville, Mass., company is planning to file a 510(k) for a nocturnal indication for its System One home hemodialysis system by March after recently wrapping up a clinical trial, CEO Jeff Burbank said during a Jan. 13 session at the J.P. Morgan Healthcare Conference in San Francisco. System One is indicated for home use, but not specifically nighttime use, and patients usually undergo five to six dialysis sessions per week, the exec noted. The NxStage device is the only home hemodialysis system cleared by FDA, but Baxter, already a leader in peritoneal dialysis, intends to launch its own home-based hemodialysis device in 2011 (1"The Gray Sheet" Sept. 21, 2009)
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