On Feb. 20, 2024, EnsoData announced it received FDA 510(k) clearance for technology that enables artificial intelligence (AI)-powered sleep diagnosis using FDA-cleared pulse oximetry devices.

About EnsoSleep PPG

EnsoSleep PPG enables AI-driven analysis using photoplethysmogram (PPG) signals recorded by compatible FDA-cleared pulse oximeters. By collecting and analyzing PPG signals from simple, wearable pulse oximetry devices, this technology may accelerate the identification, diagnosis and treatment of sleep-disordered breathing events.

Using data recorded by pulse oximetry devices, EnsoSleep PPG’s deep learning models automatically detect respiratory events, including sleep-disordered breathing events such as apneas or hypopneas, sleep stages and other sleep measures. According to the company’s press release, this information may be displayed and edited by a health care professional, then shared with the patient.

This latest FDA clearance follows the company’s previous FDA clearance of EnsoSleep, a diagnostic AI analysis and sleep scoring solution that uses machine learning to analyze data from traditional sleep studies.

About sleep apnea

Obstructive sleep apnea 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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