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Nightly Home Hemodialysis Gains First FDA Clearance

NxStage’s System One has received an expanded indication to treat patients overnight at home, which the company says improves quality of life.

NxStage Medical Inc.’s System One is the first hemodialysis device to receive FDA clearance for home nocturnal use. The 510(k) clearance comes six years after the agency released a guidance detailing the necessary clinical studies to support the indication. (See Also see "FDA Guidance On Nocturnal Home Hemodialysis Outlines Clinical Trial Needs" - Medtech Insight, 28 April, 2008..)

The portable System One was already the first hemodialysis system cleared for use at home, but employing the machine while patients sleep has a number of lifestyle and clinical advantages,...

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