On July 14, 2021, EnsoData announced its FDA 510(k) clearance of new capabilities and enhancements to EnsoSleep, an artificial intelligence (AI)-assisted sleep scoring solution that automates event detection in polysomnography (PSG) and home sleep apnea tests (HSAT).

About EnsoSleep

EnsoSleep is software-only medical device intended for use by physicians to assess sleep quality and aid in the diagnosis of sleep disorders. It analyzes at-home and in-lab sleep studies for adult and pediatric patients ages 13 and up.

The software analyzes physiological signals and automatically scores sleep study results, including respiratory, sleep staging, arousal and movement events. Automatically scored events and physiological signals are analyzed, displayed, and summarized for review by clinicians.

The FDA 510(k) clearance includes the addition of pediatric patients, automated scoring of Cheyne-Stokes and periodic breathing episodes, a browser-based scoring interface to view and edit sleep studies and the support of home-based sleep studies.

About obstructive sleep apnea

OSA is a prevalent and serious sleep disorder where the airway becomes repeatedly blocked during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises and frequent awakenings, potentially contributing to health issues such as high blood pressure, heart disease, stroke, diabetes and depression.

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