MONTREAL (PRWEB) February 22, 2021
NeuroServo, an early stage medical device company developing an advanced portable and wireless prefrontal EEG announced today that the company received ISO 13485:2016 certification for its R&D and production facilities in Montréal. This certification is an internationally recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes.
In January 2021, NeuroServo received the IEC/EN 60601 and 80601-2-26 certifications for VEEGix, its next-gen EEG. "These are two major milestones for our startup that now becomes a certified medical grade manufacturer with a medical grade device," said Nicolas Tremblay, President.
"Our EEG does not only capture brainwaves, it analyzes brain signals in real time with our algorithms trained to detect post operative delirium, a pathology affecting from newborns to up to a third of patients aged 65+ after a surgery," added Jérôme Arnaud, co-founder.
NeuroServo is pursuing clinical trials on delirium early detection at CHUM (Montréal), St-Justine paediatric Hospital (Montréal) and Assistance Publique / Hôpitaux de Paris.
NeuroServo is supported by CTS, Desjardins Capital, TransMedTech Institute, Innovation and AI department at CHUM, Dassault Systèmes 3DExperience Lab, PME MTL and CENTECH.
More about NeuroServo: https://www.neuroservo.com
Keywords : MedTech, medical device, startup, neuroscience, EEG, delirium