QuantalX Neuroscience Secures CE MDR Approval for Delphi-MD to Advance Brain Health Assessment in the EU
QuantalX Neuroscience has achieved a significant milestone with the CE MDR approval of its Delphi-MD neurodiagnosis device, marking a major step toward commercialization across the European Union. This certification, under the EU’s stringent Medical Device Regulation (MDR), highlights the device’s safety, efficacy, and quality, positioning it as a transformative tool in neurological care.
The Delphi-MD device is designed to provide accessible, objective, and non-invasive brain health assessments, enabling early detection and differential diagnosis of a wide range of neurological conditions, including stroke, Parkinson’s disease, dementia, Alzheimer’s disease, and Normal Pressure Hydrocephalus (NPH). By predicting individual treatment responses, Delphi-MD empowers clinicians to deliver personalized care, improving patient outcomes and quality of life.
Europe’s aging population is driving a surge in neurodegenerative diseases, placing immense pressure on healthcare systems. According to the World Health Organization (WHO), dementia alone affects 14.1 million Europeans, with care costs reaching $439 billion in 2019. Parkinson’s disease, the fastest-growing neurological disorder, impacts over 1.2 million people, and cases are expected to rise as the population ages. By 2050, the number of Europeans aged 60 and older is projected to increase significantly, further exacerbating the strain on healthcare resources.
“The CE MDR approval validates the innovation behind Delphi-MD and underscores our commitment to advancing brain health diagnostics,” said Dr. Iftach Dolev, CEO and Co-founder of QuantalX Neuroscience. “This milestone marks the beginning of a new era in neurological care, where early detection and precise diagnosis can significantly improve patient outcomes and reduce the economic burden on healthcare systems.”
The Delphi-MD device will be deployed in neurological care centers, hospital neurology departments, and brain health networks across Europe. Its ability to streamline brain health assessments and provide actionable insights will not only enhance clinical decision-making but also alleviate the financial and operational challenges faced by healthcare providers.
QuantalX Neuroscience’s achievement reflects its dedication to innovation and excellence in neurological care. With CE MDR approval secured, the company is poised to make a meaningful impact on brain health diagnostics, offering hope to millions of patients and their families while transforming the landscape of neurological care in Europe.
