Switzerland-based Sleepiz AG recently earned [Conformitè Europëenne] certification for its Sleepiz One, a contactless sleep tracker that uses wireless millimeter wave technology, sensor fusion, and artificial intelligence to monitor sleep.
The device is now undergoing additional clinical trials to get validated as a European Medical Device Regulations Class IIa medical device for diagnosis. Sleepiz plans on entering the sleep apnea diagnosis market starting with Switzerland, Germany, and other selected European markets and the United States.
“More than 1 billion people suffer from sleep apnea and 250 million from chronic obstructive pulmonary disease,” says Sleepiz CEO Soumya Dash in a release. “We set out to improve outcomes in respiratory related illnesses with AI-based long-term monitoring during sleep and at home.”
In March 2020, the quality management system of Sleepiz was ISO 13485 certified.