Sleepiz One+ (2.5)
Sleepiz AGSleepiz One+ (2.5) is a contactless medical device that uses Doppler radar technology to measure heart rate and respiration rate in adult patients at rest or during sleep. It detects patient presence and body movements, allowing healthcare professionals to monitor these vital signs remotely either in clinical or home settings through cloud-based software. It aids clinicians by providing continuous non-contact monitoring without the need for wearable devices or electrodes.
Intended Use
Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition) and to detect patient presence and body movements. It is intended for use by healthcare professionals in clinical settings or by patients and caregivers at home. It is not indicated for active patient monitoring requiring alarms, use on pregnant women, or patients with active implantable devices.
Technology
Sleepiz One+ uses Doppler radar in a hardware unit to non-invasively detect small body movements caused by breathing and heartbeat. The radar data is transmitted wirelessly to cloud software, where AI-based analytics process signals to extract respiration rate, heart rate, body movements, and other statistics. The device includes embedded firmware, sleep analytics software (ML model), and cloud backend services including APIs for healthcare professionals.
Performance
Verification and validation testing, including software verification (IEC 62304), electrical safety (ANSI/AAMI standards), and electromagnetic compatibility (IEC 60601-1-2), were performed. Non-clinical testing confirmed design outputs met input specifications and demonstrated that the device is safe, reliable, and performs comparably to the predicate device Sleepiz One+. No new safety or effectiveness concerns were identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/1/2025
2 months - 2
FDA Approval
7/29/2025
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