fda

FDA Approved

  • SleepImage is a revolutionary approach to managing sleep health in both children and adults.
  • It is in compliance with the EU Medical Device Directive and is U.S. Food and Drug Administration (FDA) cleared Software as a medical Device (SaMD) that establishes Sleep Quality.
  • SleepImage can be used for:
    • Measure sleep quality
    • Measure sleep duration
    • Evaluate sleep disorders
    • Aid diagnosis of sleep apnea
    • Track sleep disorder