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
Related news
Meet with an expansion expert
Our services are free of charge and include:
- Introduction to key contacts in industry, academia, and government
- Advice on regulatory framework, taxes, labor, market, and setting up a company
- Custom-made fact-finding visits, including office and co-working space