iVision Tech S.p.A. announces that the iSee smart glasses are officially registered with the Italian Ministry of Health as a Class 1 Medical Device.
The CE Declaration of Conformity certifies that the device meets the safety and performance requirements set by EU Regulation 2017/745 for Class 1 medical devices.
iSee is an extremely innovative and fully Made in Italy product: entirely designed and developed by the R&D department of iVision Tech. The glasses enable blind users to scan their surroundings up to four meters away and detect up to 30 objects simultaneously, increasing their autonomy and ensuring greater safety during movement.
In January, iVision Tech had already obtained the patent for the industrial invention of the iSee glasses, titled “Wearable visual assistance device, particularly for blind and/or visually impaired individuals.”
Orders are already available via the e-commerce platform isee-one.com, and—as previously announced—distribution of the iSee smart glasses will begin next week.
Federico Fulchir, Project Manager of the iSee Project at iVision Tech, stated:
“We are proud and excited to announce that iSee has been successfully registered ahead of schedule as a Class 1 medical device, making it eligible for government contributions related to visual disabilities. Seeing the results of a journey that began over two years ago is truly rewarding. We continue to work on refining its capabilities every day, confident that it will significantly improve the lives of many people.”
Here is the dedicated interview, from Class CNBC:
