Sleepiz received FDA Class II 510(k) clearance for Sleepiz One+, a contactless device intended to measure heart rate and respiration rate in adult patients at rest or during sleep.
About Sleepiz One+
Sleepiz One+ uses Doppler radar technology to provide passive vital signals. The device is placed beside the bed, mounted slightly higher than the mattress level, where it detects the presence of the patient and their physiological signals. According to the company, the Sleepiz One+ unit allows contactless detection of heart rate and respiration rate by sensing chest displacements originating from heartbeats and breathing activity of patients.
The recorded signals are transmitted to cloud software, analyzed, and then displayed in a web application. The data can be accessed by a health care professional for retrospective analysis to remotely monitor the patient’s physiological status.
With the FDA clearance, physicians can prescribe the Sleep One+ patients. Patients can also monitor their vital signs at home.
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