QuantalX Neuroscience Ltd. has announced that its innovative brain health assessment device, Delphi-MD, has earned CE MDR approval, meeting the rigorous standards of the European Union’s Medical Device Regulation (MDR). This approval marks a significant step toward the commercialization of the device across Europe, advancing the company’s mission to enhance patient outcomes and reduce the financial strain on healthcare systems.
The CE MDR certification ensures that Delphi-MD adheres to the highest standards of safety, efficacy, and quality, positioning the device as a leader in neurodiagnosis. The device is poised to be deployed in neurological care centers, neurology departments, and brain health networks, offering a reliable and accessible method for the early detection and diagnosis of various neurological conditions. These include stroke, Parkinson’s disease, dementia, Alzheimer’s disease, and Normal Pressure Hydrocephalus (NPH), among others. Additionally, Delphi-MD will help predict individual patients’ responses to treatments, further optimizing patient care.
The approval comes at a time when Europe is facing a surge in neurodegenerative diseases due to an aging population. The World Health Organization (WHO) reports that 14.1 million people in Europe were living with dementia in 2019, a condition that cost the region $439 billion that year. Parkinson’s disease, the fastest-growing neurological disorder, affects over 1.2 million Europeans, with numbers expected to rise as the population ages. By 2050, the number of Europeans aged 60 and older is anticipated to grow substantially, placing additional pressure on healthcare systems.
Dr. Iftach Dolev, CEO and Co-founder of QuantalX, expressed his excitement about the approval: “CE MDR approval validates the unparalleled innovation behind our neurodiagnosis test. It’s a testament to our team’s dedication and marks the beginning of a new era in brain health diagnostics.”
With its ability to offer early and precise diagnosis, the Delphi-MD will play a pivotal role in improving patient outcomes, enhancing quality of life, and easing the growing clinical and economic burdens on European healthcare systems.
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