NxStage Medical clarification
Firm's System One daily home hemodialysis system is for dialysis treatment, and the latest results of the ongoing FREEDOM study showed that fewer patients treated with the device experienced restless legs syndrome symptoms versus baseline and that overall sleep quality improved after four months. "The Gray Sheet" (1March 22, 2010) originally misstated the intended use of the device
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FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.