Sleepiz One+ granted approval in the USA

12 October 2023 10:50

Zurich CCGreater ZurichSwiss AMCHAM SoCal

Zurich - The Sleepiz device for contactless remote monitoring of a patient’s vital signs has been approved for use as a medical product by the US Food and Drug Administration. This means that the small cube-shaped device, which is placed on a bedside table during the night, can now be prescribed by doctors in the USA as well.

The sleep monitor Sleepiz One+ from the Zurich-based company Sleepiz has been approved by the US Food and Drug Administration (FDA) for use as a medical product. The small cube is placed next to the bed to measure a patient’s macro and micro movements in a contactless manner to determine their vital signs. These can contribute to the early detection of deteriorating health in patients, for example in the case of chronic illnesses.

As the spin-off from the Swiss Federal Institute of Technology in Zurich (ETH) writes in a press release, the FDA approval opens the door to the seamless integration of the Sleepiz One+ in remote patient monitoring processes and clinical trial platforms in the USA as well. Sleepiz was awarded the European Union’s CE mark back in October 2020.

“Sleepiz One+ shifts us from a wired, wearable world to a completely wireless, continuous standard of care”, comments Dr. Soumya Dash, CEO of Sleepiz, in the press release. With the FDA approval, 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”, Dash concludes. ce/mm

Swiss Pavilion Digital