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# FDA Clears EnsoData Sleep Monitoring Software
- URL: https://www.fdaweb.com/fda-clears-ensodata-sleep-monitoring-software/
- Published: 2017-04-14T12:00:00.000Z
- Updated: 2026-09-14T22:17:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138452

FDA has cleared an EnsoData 510(k) for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals and automatically score sleep study results. EnsoSleep is intended for use for the diagnostic evaluation by physicians to assess sleep quality and as an aid in diagnosing adult sleep and respiratory-related sleep disorders, according to the company. “EnsoSleep’s proprietary sleep scoring and event detection algorithms are based on current American Academy of Sleep Medicine (AASM) guidelines,” the company says. “EnsoSleep intelligently automates the recognition and annotation of sleep staging, respiratory events, arousals, and movement events.”  

The software’s clinical performance was validated in a clinical study with signals acquired from the most popular sleep-scoring systems, EnsoData says. “The results compared automatically detected sleep staging, sleep-disordered breathing, apnea hypopnea index, apneas, obstructive apneas, arousals, and leg movements with scoring results obtained from a majority consensus between several experienced sleep technologists, providing evidence of the clinical performance of EnsoSleep automated sleep scoring that was utilized to support the decision for FDA clearance.”