Breaking news! We are proud to announce that Restorative Neurotechnologies is the first Italian Medtech company to obtain a MDR based Class IIa certification for cognitive rehabilitation.
Last week, DNV Product Assurance AS has certified that the Restorative Neurotechnologies’ Quality Management System complies with the requirements of the new European Union Medical Device Regulation (MDR) 2017/745. In particular, our flagship product MindLenses Professional has been certified as a Class IIa Medical Device.
The press release about this news can be accessed here.
What does this mean in practice?
The certification means that MindLenses can now be fully commercialized throughout Europe – a launch we have been preparing for a year by signing several deals with medical device distributors and service providers in Europe. It also means that MindLenses is now eligible for inclusion in reimbursement pathways within national public health systems in Europe.
From now on, Restorative Neurotechnologies is starting procedures to enter reimbursement paths reserved to CE-marked digital therapies.
What has the certification entailed?
The European Union’s Medical Device Regulation replaced the earlier Directive 93/42/EEC (MDD), with the purpose of ensuring that medical devices are safe and perform as intended. The rigorous certification process, which took two years, subjected MindLenses to comprehensive assessments of the product’s technical documentation, clinical evaluations and evidence, patient outcomes and the implementation of a robust Quality Management System – the latter already certified according to ISO 13485 in 2022.
This achievement has been reached thanks to the relentless efforts of our QARA Director and Clinical Manager, Agnese Di Garbo, who lead an internal team and coordinated various advisors for more than two years.
About MindLenses Professional
MindLenses Professional is an innovative and non-invasive digital therapy that combines neuromodulation through the use of prismatic lenses together with a suite of Serious Games developed by neurologists and psychologists and used by the patients, as well as a Web portal allowing the physicians to access patient and clinical data. Two clinical trials carried out during the last three years have demonstrated the clinical performances and benefits of MindLenses for the rapid rehabilitation of impaired cognitive functions (for example: attention, language, memory and ability to interact socially) of patients following a stroke. Similar clinical evidence and performances have been demonstrated for patients suffering from neurodevelopmental disorders, particularly ADHD (Attention/Deficit Hyperactivity Disorder) and Dyslexia. The main competitive advantages of MindLenses Professional consist in a shorter protocol (10 days) instead of the weeks or months of the alternatives, together with higher clinical outcomes for the rehabilitation of the cognitive functions of the patient (30% higher compared to alternatives) with long-term benefits.
MindLenses is already on the market in Italy as a Class I Medical Device and currently adopted by over 50 major public and private hospitals and rehabilitation centers. Over 1800 patients have already benefited from MindLenses, either through inclusion in clinical trials or through the prescription of the therapy by healthcare professionals in Italy.
If you are a medical professional or a distributor and what to know more about MindLenses, you can book an appointment with us at this link.
