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SleepImage Ring

SleepImage is cleared by the U.S. Food and Drug Administration (FDA) for the diagnosis and management of sleep disordered breathing. SleepImage is considered Software as a Medical Device (SaMD), which the FDA defines as “software intended to be used for one or more medical purposes…without being part of a hardware medical device.” SleepImage software is most commonly used with the SleepImage Ring as the hardware device, but it is compatible with other hardware devices.

The SleepImage Ring is simple to use and comfortable to wear without compromising output quality, making it a suitable choice for people who prefer not to use at-home tests that require many different components.

During the sleep study, the user’s raw physiological data is streamed from the ring to a mobile app which then uploads the data to the SaMD, where the data is analyzed and auto-scored. The extensive data can be reviewed by the reading physician, interpreted, and manually scored for diagnosis of obstructive sleep apnea (OSA) and central sleep apnea (CSA). The SleepImage system can be used in children over the age of 2 and adults.

SleepImage is a prescription medical device that is sold to licensed health care professionals for use with the people they treat. We’ll explain how the SleepImage Ring works, what it measures, and what users can expect to pay. We’ll also cover who might find this device beneficial and who should look for a different type of at-home sleep apnea test.

The SleepImage System Output is based on collecting signals controlled by the autonomic nervous system during sleep to measure:

  • Wake vs. sleep
  • Sleep states (NREM vs. REM)
  • Sleep stages (stable vs. unstable NREM)
  • Objective sleep quality using the FDA-cleared Sleep Quality Index (SQI)
  • Respiration
  • Blood oxygenation (SpO2)
  • Movement (actigraphy)

The SleepImage System is FDA-cleared to provide comparable output to a polysomnography (PSG) test for diagnosing obstructive and central sleep apnea, using auto-scoring of the SleepImage Apnea Hypopnea Index (sAHI) that the doctor can manually review and re-score if desired for respiratory events using the raw data collected from the patient.