Sleepiz lands FDA 510(k) clearance for monitoring device
Sleepiz, a Zurich-based medical technology company providing contactless bedside patient monitoring, has announced the FDA Class II 510(k) clearance of its Sleepiz One+ device.
Sleepiz One+ is a small device placed on a bedside table that measures the macro and micro-motion in a contact-free manner to extract vital signs, which can assist with the early detection of deterioration in patients with chronic medical conditions.
The FDA clearance opens doors for 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 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 US for RPM and long-term monitoring – empowering over 34 million people in the US.
“Sleepiz One+ shifts us from a wired, wearable world to a completely wireless, continuous standard of care,” said Dr. Soumya Dash, Sleepiz CEO. “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.”
With an accuracy rate of 99% in breathing rate and 96% in heart rate measurements compared to gold standard methods, Sleepiz is "revolutionising healthcare and enhancing the quality of care for patients and healthcare professionals alike".
Physicians can now prescribe the Sleepiz One+ to their patients. This 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.
Patients can monitor vital signs from the comfort of their own homes. The contactless Sleepiz One+ device is designed for ease of installation and use, offering continuous, uninterrupted, and accurate health status checks at their bedside.
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.
“We are grateful to our regulatory management software partner, Essenvia, for helping us to achieve this important milestone,” continues Dr. Dash. “Essenvia's easy-to-use MedTech-centric platform, combined with their team's dedicated support, expertise, and extensive experience at every step, including the 510(k) submission process, enabled us to navigate our FDA 510(k) clearance with confidence and peace of mind.”