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.
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.”
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.
Source: Company Press Release