Michael Barbella, Managing Editor12.12.23
Sleepiz has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Sleepiz One+, a small device that measures the macro and micro-motion in a contact-free manner to extract vital signs.
The FDA clearance opens 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.
While providing peace of mind for the patients, physicians can reimburse the use of the device using Current Procedural Terminology (CPT) codes for RPM to bring in additional revenue. In the remote patient monitoring world, 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 U.S. patients suffering from chronic respiratory diseases for RPM and long-term monitoring.
“Sleepiz One+ shifts us from a wired, wearable world to a completely wireless, continuous standard of care,” Sleepiz CEO Dr. Soumya Dash said. “With this FDA 510(k) clearance, Sleepiz has achieved a critical milestone in the highly regulated medical device market. This is just one more step towards creating the future of healthcare.”
Sleepiz One+ has a 99% accuracy in breathing rate and 96% accuracy in heart rate measurements compared to gold standard methods. The device offers short- and long-term respiration and heart rate monitoring, providing enhanced insights into patients' physiological statuses. It sheds light on disease progression or remission, allowing for timely interventions and patient-centric care. The contactless Sleepiz One+ device enables patients to monitor their vital signs at home; it is easy to install and use, offering continuous, uninterrupted, and accurate health status checks at the bedside.
Company executives claim Sleepiz One+ will impact projects across various healthcare sectors including:
Sleepiz AG Ltd. is a Zürich based startup that aims to provide patient-centric disease management through seamless integration of contactless monitoring. The firm leverages the power of sleep insights with a device that is simply placed on the bedside table. The device—also approved for market in Europe—operates in a non-contact fashion and measures movements originating from heart contractions and breathing patterns, as well as body motions.
The FDA clearance opens 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.
While providing peace of mind for the patients, physicians can reimburse the use of the device using Current Procedural Terminology (CPT) codes for RPM to bring in additional revenue. In the remote patient monitoring world, 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 U.S. patients suffering from chronic respiratory diseases for RPM and long-term monitoring.
“Sleepiz One+ shifts us from a wired, wearable world to a completely wireless, continuous standard of care,” Sleepiz CEO Dr. Soumya Dash said. “With this FDA 510(k) clearance, Sleepiz has achieved a critical milestone in the highly regulated medical device market. This is just one more step towards creating the future of healthcare.”
Sleepiz One+ has a 99% accuracy in breathing rate and 96% accuracy in heart rate measurements compared to gold standard methods. The device offers short- and long-term respiration and heart rate monitoring, providing enhanced insights into patients' physiological statuses. It sheds light on disease progression or remission, allowing for timely interventions and patient-centric care. The contactless Sleepiz One+ device enables patients to monitor their vital signs at home; it is easy to install and use, offering continuous, uninterrupted, and accurate health status checks at the bedside.
Company executives claim Sleepiz One+ will impact projects across various healthcare sectors including:
- Hospital at Home: Facilitating hospital-level monitoring and care in patients' own 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.
Sleepiz AG Ltd. is a Zürich based startup that aims to provide patient-centric disease management through seamless integration of contactless monitoring. The firm leverages the power of sleep insights with a device that is simply placed on the bedside table. The device—also approved for market in Europe—operates in a non-contact fashion and measures movements originating from heart contractions and breathing patterns, as well as body motions.