News and Press Releases
Neurotech International’s At Home Therapy Device Mente receives CE mark renewal for use with ASD Children
Neurotech International Limited (ASX: NTI) (“Neurotech” or the “Company”), developer of quality medical solutions in the neuroscience space, announces that Mente has successfully renewed its CE marking. This confirms Mente’s unique position as a medical-neurofeedback device designed for use at home in the management of autism. It is the world’s only clinically proven at home therapy for ASD children.
Mente is classified as a Class IIa medical device and the Company also holds ISO 13485:2016 certification, provided to companies which meet the requirements and standards to design, manufacture and distribute medical devices.
The CE renewal audit was conducted by the independent body, ITALCERT, which evaluated the quality management system of the Company and the compliance of the Mente device to the European standards of health, safety and effectiveness for its intended use in the management of neurodevelopmental disorders, such as autism.
Peter Griffiths, CEO of Neurotech International said: “This is another important milestone for the Company. Over the past year, we have listened to feedback from our customers and distribution partners and many of the improvements we have introduced reflect this feedback. With CE certification, Neurotech meets all the required standards and policies required of an organization in this market.”
An autism breakthrough, clinically proven Mente helps ASD children to learn to engage positively with their environment.
Mente continues to gain acceptance around the world. Autism Parenting Magazine in the US featured Mente in an article in its latest issue.
Mente is the world’s only personalised at home neurofeedback therapy clinically proven to help children with ASD self-regulate mood and behaviour.
Mente is available through www.mentetech.com