The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Sleepiz One+, a contactless remote patient monitoring device that collects biometric data and records vital signs from the user’s bedside table while they sleep.

Sleepiz One+, a small device placed on a bedside table, 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 clearance opens doors for integration of the Sleepiz One+ device into remote patient monitoring and clinical study platforms. This integration gives healthcare professionals 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 remote patient monitoring. Sleepiz One+ allows for 16 out of 30 days of measurements for CPT billing purposes. The FDA clearance now makes Sleepiz available to patients with chronic respiratory diseases in the US for remote patient monitoring and long-term monitoring.

“Sleepiz One+ shifts us from a wired, wearable world to a completely wireless, continuous standard of care,” says Soumya Dash, PhD, CEO of Zürich-based startup Sleepiz, in a release. “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 is shown to have an accuracy rate of 99% in breathing rate and 96% in heart rate measurements compared to gold-standard methods.

With the FDA clearance:

  • 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.

Photo caption: Sleepiz One+

Photo credit: Sleepiz