The US Food and Drug Administration (FDA) has cleared Sleepiz’s bedside device that monitors patients’ vital signs during sleep.
The Sleepiz One+ device uses radar technology for contactless monitoring of breathing patterns, respiration rate and heart rate during sleep. The device uses proprietary artificial intelligence (AI) to transform macro and micro-motion signals into statistics for healthcare professionals.
The FDA Class II 510(k) clearance means physicians can now prescribe the device to their patients for sleep apnoea screening at home, in addition to monitoring of vital signs.
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Minnesota, US-based Sleepiz states the device could be deployed in scenarios where remote patient monitoring is required for patients with chronic respiratory illnesses – of which there are more than 34 million in the US, according to the American Lung Association.
A 2022 report by GlobalData forecasts that the remote patient monitoring device market will reach $760m by 2030. The market will exhibit a compound annual growth rate of 3.3% from 2020 to 2030.
Data published in Scientific Reports indicates the device can measure breathing rate and heart rate with 99% and 96% accuracy, respectively, compared with gold standard methods.
