Sleepiz achieves first medical device certification!

EIT Health Headstart and Catapult winner Sleepiz announces CE clearance for its first medical product Sleepiz One.

Sleep loss and sleep disorders are among the most common yet frequently overlooked and readily treatable health problems. Diagnosing sleep disorders today requires a patient to spend the night at a hospital while attached to lots of cables and being monitored by a technician. This is costly, consumes the time of medical professionals, and it requires patients to sleep in an unfamiliar place, rather than their own bed, where their sleep will be more natural and typical.

Addressing this issue, Sleepiz developed a unique solution that enables the patient’s sleep to be monitored wirelessly at home, using very high-frequency technology and artificial intelligence to interpret sleep patterns, With wireless signals, Sleepiz’ device measures vital signs without touching the patient – enabling non-contact home diagnosis of sleep apnoea and other sleeping disorders.

While currently focusing on respiratory illnesses, Sleepiz aims to improve people’s lives by creating the future of healthcare. By making use of wireless millimeter wave technology, sensor fusion and artificial intelligence, in the future, Sleepiz will not only be able to diagnose sleep disorders but also perform long-term monitoring. Thereby, the progression of chronic diseases will be monitored to allow faster intervention and better treatment.

“More than 1 billion people suffer from Sleep Apnea and 250 million from Chronic Obstructive Pulmonary Disease (COPD). We set out to improve outcomes ​in respiratory-related illnesses ​with AI-based ​long-term monitoring ​​during sleep and at home​.” states Soumya Dash, CEO of Sleepiz.

Since its founding in 2018, the startup has seen continuous progress. Besides the collaboration with closely with leading clinics in Switzerland and Europe, the ETH spin-off has won 14 start-up awards and grants including W.A. de Vigier Top 10,  >>venture>> 2019-Health & Nutrition and EIT Health Germany Headstart Grant, while also receiving backing from Innosuisse and the European Commission within the Horizon 2020 program.

On 1 October 2020 their product Sleepiz One officially received its CE Class I clearance, following a major milestone in March 2020, when the quality management system of Sleepiz got ISO 13485 certified. This has qualified Sleepiz as a medical device manufacturer with an emphasis on the safety and efficacy of medical devices. The product is now undergoing additional clinical trials to get validated as a Class IIa medical device for diagnostic purposes according to the European Medical Device Regulations.

Congratulations to the team!