Onera Health announced that its subsidiary in the Netherlands, Onera B.V., received FDA 510(k) clearance for Onera Sleep Test System (STS), a wearable patch-based system for polysomnography studies.
About Onera STS
Onera STS consists of four sensors applied to the forehead, upper chest area, abdominal and lower leg area. It measures and records multiple physiological parameters, including electroencephalography, electrooculography, electromyography and electrocardiography signals, as well as oxygen saturation, respiratory effort, respiratory flow, activity, position and sound pressure level. The recorded data is available to a health care professional to assist in the diagnosis of sleep disorders.
Onera STS is intended to be used on adult patients who have been prescribed a sleep study. The device can be used in home health care environments and professional health care facilities.
According to the company, the European commercial launch is slated for the second half of 2022, with plans to extend to the American market.
About sleep disorders
Sleep disorders are conditions that disrupt normal sleep patterns, affecting the quality, amount and timing of sleep. With an estimated 70 million people worldwide experiencing sleep disorders, these conditions can contribute to physical and mental health problems.
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