Nihon Kohden Unit Wins FDA Clearance for Sleep Analysis Software

PUBT · 2d ago
Nihon Kohden Unit Wins FDA Clearance for Sleep Analysis Software
  • Nihon Kohden’s Neurotronics received FDA 510(k) clearance for its Sleep Analysis Module, its first FDA-cleared AI/ML-based sleep analysis algorithm.
  • The software estimates total sleep time from existing pulse oximetry signals without additional sensors; initial integration is planned for Polysmith software.


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