The SleepizOne+ device measures macro and micro-motion of patients in a contact-free manner to extract vital signs. The clearance from the U.S Food and Drug Administration paves the way to offering the device in the US. Physicians can now prescribe the Sleepiz One+ to their patients.
Sleepiz is a Zurich-based medtech company providing contactless bedside patient monitoring. The startup leverages the power of sleep insights with a device that is simply placed on the bedside table. The device operates in a non-contact fashion and measures movements originating from heart contractions and breathing patterns, as well as body motions. These insights can assist with the early detection of deterioration in patients with chronic medical conditions.
Sleepiz One+ has received CE class IIa medical device certification in Europe and just recently, the FDA class II 510(k) clearance in the US, opening doors for seamless integration of the Sleepiz One+ device into Remote Patient Monitoring (RPM) and clinical study platforms. This integration empowers healthcare professionals with comprehensive respiration and heart rate monitoring capabilities, delivering medical data for actionable insights and informed decision-making.
Physicians can reimburse the use of the device using Current Procedural Terminology (CPT) codes for RPM to bring in additional revenue while providing peace of mind for the patients. In the world of remote patient monitoring, compliance is key, and Sleepiz One+ allows for 16 out of 30 days of measurements for CPT billing purposes. The FDA clearance now makes Sleepiz available to patients suffering from chronic respiratory diseases in the U.S. for RPM and long-term monitoring – empowering over 34 million people in the U.S.
With an accuracy rate of 99 percent in breathing rate and 96 percent in heart rate measurements compared to gold standard methods, Sleepiz is revolutionizing healthcare and enhancing the quality of care for patients and healthcare professionals alike.
Sleepiz One+ will impact projects across various sectors within the healthcare ecosystem, including:
- Hospital at Home: Facilitating hospital-level monitoring and care in the comfort of patients' homes.
- Pharmaceuticals: Enabling accurate and compliant health data collection for clinical trials and research studies.
- Skilled Nursing Facilities: Enhancing patient care by providing continuous monitoring for vulnerable and/or elderly individuals.
- Assisted Living: Supporting the elderly with unobtrusive health monitoring to maintain their independence.
- Health/Wellness: Providing individuals with insights into their overall health and well-being.
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