Sleepiz AG Has Secured FDA 510(K) Clearance for Its Contactless Remote Patient Monitoring Device, Which Can Measure Vital Signs.

Wednesday, October 11, 2023

Sleepiz, a medical technology company based in Zurich, has announced that it has received FDA Class II 510(k) clearance for its Sleepiz One+ device. This device, designed to be placed on a bedside table, employs contactless methods to measure both macro and micro-movements to extract vital signs. These measurements are invaluable for the early detection of health deterioration in patients with chronic medical conditions.

The FDA clearance allows for the smooth integration of the Sleepiz One+ device into Remote Patient Monitoring (RPM) and clinical study platforms. This integration equips healthcare professionals with comprehensive monitoring capabilities for respiration and heart rate, providing essential medical data for informed decision-making.

Moreover, in addition to offering peace of mind to patients, this clearance enables physicians to use Current Procedural Terminology (CPT) codes for reimbursement when utilizing the device. In the realm of remote patient monitoring, compliance is a key factor, and Sleepiz One+ allows measurements for CPT billing purposes on 16 out of 30 days. This regulatory approval now makes Sleepiz available to more than 34 million individuals in the United States who suffer from chronic respiratory diseases, supporting RPM and long-term monitoring.

Dr. Soumya Dash, the CEO of Sleepiz, expressed, "Sleepiz One+ shifts us from a wired, wearable world to a completely wireless, continuous standard of care. Obtaining the FDA 510(k) clearance marks a pivotal achievement for Sleepiz within the tightly regulated medical device market. It signifies yet another stride forward in shaping the future of healthcare. 

Boasting an exceptional 99 percent accuracy in measuring breathing rates and 96 percent in heart rate measurements, Sleepiz is driving a revolution in healthcare. This advancement significantly elevates the quality of care for both patients and healthcare professionals.

Now, physicians have the ability to prescribe the Sleepiz One+ to their patients, heralding a new era of personalized healthcare. This versatile device offers both short- and long-term monitoring of respiration and heart rate, providing valuable insights into patients' physiological status. It aids in identifying disease progression or remission, enabling timely interventions and patient-centric care.

Patients can conveniently monitor vital signs from their own homes. The contactless Sleepiz One+ device is designed for easy installation and use, providing continuous, uninterrupted, and accurate health status checks at the bedside.

Sleepiz One+ is poised to impact various sectors within the healthcare ecosystem, including:

1.Hospital at Home: Facilitating hospital-level monitoring and care in the comfort of patients' homes.
2. Pharmaceuticals: Sleepiz empowers precise and compliant collection of health data for use in clinical trials and research studies.
3. Skilled Nursing Facilities: Enhancing patient care by providing continuous monitoring for vulnerable and/or elderly individuals.
4. Assisted Living: Facilitating unobtrusive health monitoring to help the elderly maintain their independence. 
5. Health/Wellness: Offering individuals insights into their overall health and well-being.

Dr. Dash acknowledges the support of Essenvia, their regulatory management software partner, in achieving this important milestone. He expresses his gratitude, saying, "We appreciate the invaluable support of our regulatory management software partner, Essenvia, in reaching this significant milestone. Essenvia's user-friendly MedTech-centric platform, coupled with their committed team's expertise and extensive experience at every stage, including the 510(k) submission process, provided us with the confidence and peace of mind needed to navigate our FDA 510(k) clearance process."

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