Lumeen, our therapeutic virtual reality tool, is now CE marked as a class 1 medical device. This certification is a testament to our efforts to scientifically validate the clinical impact of our virtual reality headsets and programs.

‍

‍

Virtual reality as a medical device: an efficiency recognized worldwide

‍

A medical device is a tool that is used for medical purposes but is not a medicine. Thus, digital medical devices such as Lumeen fit perfectly into non-drug therapies (TNM) promoted by the Haute Autorité de Santé since 2011.

‍

Lumeen is one of the European pioneers in applying a CE class 1 medical device marking for a virtual reality solution for therapeutic purposes. For this certification, we relied on an international scientific literature review of 24 references. It will be completed by our clinical investigations in progress. For dependent elderly people, our literature review exposes psychological and cognitive benefits. In the hospital sector, numerous studies show a reduction in anxiety and pain before and after surgery, allowing a reduction in premedication.

‍

‍

Clinical validation committed with recognized scientists

‍

Launched at the end of 2018, our clinical validation strategy is gaining momentum. We have set up research partnerships with major hospital centers such as the Hospices Civils de Lyon, the Hospitals of Paris and academic partners such as the University of Paris and the Gérontopôle Ile-de-France. Two research projects are currently being tested and three others are in the protocol drafting stage.

‍

In addition to strengthening our scientific credibility, this certification will streamline our research collaborations. Indeed, a CE marking makes it possible to speed up the process of validating protocols with personal protection committees.

‍

‍

Do you want to know more?

‍

➡️ We are looking for scientific partners who are interested in the potential of virtual reality. If you want to learn more about our scientific work, visit our search page.