Touching lives without touching
Sleepiz One+ is the first EU MDR, Class IIa certified non-contact respiration monitor
Hornbachstrasse 23 | 8008 Zurich | Switzerland
Sleepiz AG Team Zürich and remote team (inset) celebrating the CE IIa certification
Press Release December 2021
ZÜRICH – Sleepiz AG, a Zürich-based medical technology start-up has received CE Class IIa certification, in accordance with the new European Medical Devices Regulations (EU MDR). This makes Sleepiz One+ the first certified non-contact device for vital sign monitoring in Europe.
Relentless efforts and a series of reviews on different expertise levels and clinical studies led Sleepiz AG to achieve the CE Class IIa certification for Sleepiz One+. With this certification, the EU MDR regulations intend to ensure a high standard of safety and quality for medical devices as well as standardizing data and technological advances.
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For physicians, this certification implies that they can now prescribe Sleepiz One+ to their patients for short- or long-term respiration monitoring to receive better insights into their physiological status and the progress or remission of their disease.
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For patients, this means that they can enjoy the comfort of their own home while being monitored with an easy to install and use wireless medical device at their bedside, knowing that their health status is being checked effortlessly, and continuously.
Why is respiration rate monitoring so important?
Vital signs give us a glimpse into our health status. The main vital signs routinely monitored by medical professionals include pulse rate, SpO2 and respiration rate. The respiration rate is usually measured manually, by counting how many times the chest rises per minute, as this provides the number of breaths a person takes per minute. The certified Sleepiz One+ device is the first respiration monitor to observe and record patients in a contactless manner. The technology surpasses the manual-monitoring gold standard and the currently used polysomnography used in sleep labs by far in terms of ease and accuracy.
With Sleepiz devices, entirely new insights can be derived regarding a patient’s health and physicians no longer need to rely on spot-check measurements as they can now benefit from continuous data and trend analyses. This is of significant value as a change in the respiratory rate is the first indications of health deterioration.
Abnormal respiration rates are one of the key early predictors of pneumonia (e.g. in COVID-19 patients), cardiac arrests, or exacerbations of patient with a chronic obstructive pulmonary disease. Respiration rates of above 25 are linked with 21% higher mortality rates and intensive care hospitalizations. Benefits of systematic long-term monitoring of breathing rate lead to early detection of health issues, leading to quick response times and, therefore the provision of a healthcare safety net for patients and their families.
The Sleepiz offering
Sleep Apnea Screenings
While Sleepiz launched its contactless sleep apnea screenings via www.apnoe-screening.ch/ in October 2021, physicians can now also book the Sleepiz screenings service, which is reimbursed by Swiss insurances.
Remote Patient Monitoring
With the fully certified Sleepiz One Connect System and the Sleepiz remote CARE team, Sleepiz now monitors COVID-19 patients who are at risk of deterioration. In the renowned Indian hospital chain – AIIMS, the branch in the city of Patna is already benefitting from the Sleepiz telehealth platform, which helps caregivers identify and act upon patient deterioration before it's too late.
When Sleepiz closed its Series A round of funding of CHF4.4m in August, the company decided to expand its portfolio to remotely monitor patients with chronic respiratory disease.
With this certification, Sleepiz has achieved a critical milestone and received a "ticket to play" in the highly regulated medical device market. This is just one more step towards creating the future of healthcare.
