Vivior-systeem goedgekeurd voor CE-markering – marktintroductie volgt dit jaar in Europa
ZURICH–(BUSINESS WIRE)–Vivior heeft zijn systeem gecategoriseerd gekregen als een Klasse I medisch apparaat en plant de marktintroductie later dit jaar in Zwitserland en de Europese Unie.
Dit persbericht bevat multimedia. Bekijk de volledige release hier: https://www.businesswire.com/news/home/20190326005594/en/
Vivior heeft Swissmedic geïnformeerd over hun product, de Visual Behavior Monitor, en voldoet volgens de Medical Device Directive (MDD) aan alle eisen waaraan een medisch hulpmiddel Klasse I moet voldoen. Met deze belangrijke stap mag Vivior zijn systeem nu in Zwitserland en de Europese Unie verkopen.
Mario Stark, CEO van Vivior, geeft uitleg. “We zijn blij dat we de marktintroductie kunnen starten en zullen als eerste stap met geselecteerde klinieken in Europa gaan werken”, zegt hij.
Vivior’s System Cleared for CE Mark – Market Introduction This Year in Europe
ZURICH–(BUSINESS WIRE)– Vivior has cleared their system as a Class I medical device and is planning the market introduction later this year in Switzerland and the European Union.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190326005594/en/
The Visual Behavior Monitor (Photo: Business Wire)
Vivior has notified Swissmedic about their product, the Visual Behavior Monitor, and fulfills all requirements for a medical device Class I according to the Medical Device Directive (MDD). With this important step, Vivior is now allowed to sell their system in Switzerland and the European Union.
Mario Stark, CEO at Vivior, explains: “We are happy to be able to start market introduction and will, in a first step, work with selected clinics in Europe.”
Prof. Michael Mrochen, Chairman of the Board of Directors, adds: “This constitutes an important milestone in the development of the Vivior system. We are now ready to support eye care professionals in offering the best solutions to their patients.”
About Vivior:
Vivior is a Swiss digital health start-up founded in 2017 by a group of experienced eye care professionals. The company develops a novel wearable device to objectively measure patient’s behavioral data prior to vision correction interventions. The system collects daily activity data from patients, processes these data in the cloud and analyses patient’s lifestyle patterns using machine-learning algorithms. This ground-breaking combination allows to better understand patients’ needs and enables eye care professionals to offer optimal personalized solutions to their patients.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190326005594/en/
Contacts
Vivior AG
Mario Stark
CEO
mario.stark@vivior.com
+41 79 542 88 74