HAMILTON, Ontario– VoxNeuro has received Health Canada Class II Medical Device designation for its proprietary Cognitive Health Assessment Management Platform™ (CHAMP). VoxNeuro will begin rolling out the software as a medical device across its Canadian Test Centers. This news comes hot on the heels of VoxNeuro’s FDA registration for the distribution of CHAMP as a Class II Exempt Medical Device in the US market this past May.
VoxNeuro’s industry leading neurotechnology is elevating the evaluation of cognitive function. The CHAMP software works in tandem with VoxNeuro’s Cognitive Health Assessment™, a proprietary electroencephalography protocol. By analyzing electroencephalographic event-related potential (ERP) data gathered during the assessment, CHAMP provides rapid, objective and actionable scores of four key cognitive functions: memory, information processing, attention & concentration.
Healthcare providers can use VoxNeuro’s cognitive scores to track cognitive health throughout aging, and to evaluate cognitive function when a brain disorder or symptoms related to cognitive dysfunction such as fatigue, memory loss or brain fog are suspected. Common types of brain disorders that can impact cognitive function include concussion, traumatic brain injury and dementia.
The data CHAMP provides assists clinicians in the diagnostic process, helping them make more accurate diagnoses faster. Clinicians also use the data to inform customized treatments and track how well treatments are working over time, thus helping to ensure the best possible outcomes for patients.
“The Health Canada designation will enable VoxNeuro to accelerate the expansion of our technology across the country,” said Dr. John F. Connolly, Chief Science Officer and Co-Founder of VoxNeuro. “This innovation is a significant step forward in providing dedicated clinicians with tools to better evaluate their patients’ conditions, in turn, leading to more positive patient outcomes.”
Dr. Connolly said bringing VoxNeuro’s breakthroughs to market is the result of a dynamic innovation ecosystem in Canada, particularly in its home base of Hamilton where the city, McMaster University, and McMaster Innovation Park (MIP) all played collaborative roles.
“There’s something special happening in Canada and in Hamilton, and VoxNeuro is at the center of that,” Dr. Connolly said.
Ty J. Shattuck, Chief Executive Officer of McMaster Innovation Park where VoxNeuro is headquartered, said VoxNeuro’s achievements are showcasing how the MIP ecosystem helps translate innovation to industry.
“Part of MIP’s mission is to offer a collaborative space in which to transform the ideas of our Tenant Ventures into commercial reality. VoxNeuro’s technology started at Dr. Connolly’s lab at McMaster, was incubated at The Forge, and is scaling-up with support from Innovation Factory, Synapse Life Science Consortium, McMaster Industry Liaison Office, healthcare industry leaders and other key stakeholders in our ecosystem. At each stage of a company’s growth, we’re here to help navigate and anticipate the next challenges on their road to success,” said Ty Shattuck. “VoxNeuro’s achievement of medical device designation through Health Canada is a win for Canadian-made technology.”
Alex Muggah, Director of Synapse Life Science Consortium added, “The Synapse Consortium is thrilled about VoxNeuro’s recent success in securing a Class II medical device designation. It is the culmination of years of hard work and dedication by the VoxNeuro team – and they deserve it. This achievement is a representation of how Hamilton’s health ecosystem supports innovation and entrepreneurs, helping to catalyze and accelerate commercialization efforts. Synapse looks forward to continuing its support of VoxNeuro into the future.”
Dr. Karen Mossman, Vice President, Research, at McMaster University said that she’s delighted to hear that VoxNeuro was successful in achieving the Health Canada Class II Medical Device designation.
“This is another milestone for VoxNeuro and a testament to the transformative research that’s being created at McMaster – research that advances patient health and well-being,” said Dr. Mossman, McMaster’s vice-president, research. “It is still our collective goal – through the McMaster Industry Liaison Office and the Forge – to continue to support and partner with entrepreneurs like the founders of VoxNeuro in their efforts to turn their innovations into products and make a significant impact in patient health.”
Norm Schleehahn, Director of Economic Development for the City of Hamilton said, “This milestone achievement for VoxNeuro is proof that Hamilton’s life sciences industry is one of the strongest in Canada. We are proud to have played a part in helping VoxNeuro join other leading Hamilton-based companies like Triumvira Immunologics, Inc. and Fusion Pharmaceutical in making a tangible positive impact on this nation’s healthcare and innovation landscape.”
