Sleepiz achieves first medical device certification

The Sleepiz One is a small box that is simply placed on the bedside table to measure the patient’s physiological parameters. In the current state of the art, a patient’s breathing pattern is measured with a chest effort band, a nasal canula or through a manual visual analysis. All measurements are inconvenient for the patients and are not intended for long term monitoring. Sleepiz One instead measures the patient’s chest movement without touching the patient by using wireless millimetre wave technology and sensor fusion.

The device has now obtained the CE Class I medical device clearance. "The CE marking indicates that the system including the software, hardware and data transmission complies to medical norms", explains Sleepiz Cofounder Max Sieghold. The certificate allows to commercialise Sleepiz One for the use in research, pilot projects and studies and is now undergoing additional clinical trials to get validated as a Class IIa medical device for diagnosis purposes according to the European Medical Device Regulations. 

Another major milestone was achieved in March 2020, when the quality management system of Sleepiz got ISO 13485 certified. This qualifies Sleepiz as a medical device manufacturer with an emphasis on safety and efficacy of medical devices. 

First customers

Sleepiz has signed already first contracts with customers from the pharma industry which will use the device for studies. The device will also be used by hospitals.

CEO Soumya Dash says “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”. He emphasizes that “to achieve this we engage with patients and work with clinical key opinion leaders, focus on a high-profile advisory board and only hire top talent.”

While currently focusing on respiratory illnesses, Sleepiz aims to improve people’s lives by contributing to 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.