Our client V-Vision awarded for its video game to treat amblyopia.

The BerriUP accelerator has selected V-Vision to be one of the three startups that will begin their 16-week acceleration programme this October, together with a team of mentors who will support them in various areas of the business. V-vision develops its healthcare product within the field of ophthalmology and has experts in the treatment of lazy eye and vision therapies.

A dichoptic virtual reality gaming application

V-Vision has created Dicopt, an application of virtual reality dichoptic games that, combined with a patch, have been scientifically proven to accelerate recovery from amblyopia or lazy eye.

What is amblyopia? It is an eye condition that occurs when a person’s brain does not process the image coming from one of the eyes. This phenomenon is called suppression. Lazy eye is common in children, but is also being treated in adults. The most common treatment to correct this is patching, as the brain does not get the image from the eye that is not suppressed, it is “forced” to use the information from the lazy eye to compose the image.

This treatment can be reinforced with vision therapy, which uses dichoptic exercises to force the brain to process images from both eyes.

What does the regulation say about medical devices such as V-Vision?

According to MDR 754/2017, such software would be considered a medical device and would have to comply with the regulation in order to be CE marked and placed on the market. In particular, the MDCG 2020-1 provides all the steps to demonstrate the validity of the clinical association, clinical performance and technical performance.

If you have medical software and want to obtain CE marking, Episkey Medical Consulting can help you.



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