QuantalX Neuroscience Ltd. has announced a significant milestone with its brain health assessment device, Delphi-MD, receiving CE MDR (Medical Device Regulation) certification. The CE MDR certification, which sets stringent standards for safety, efficacy, and quality in medical devices, paves the way for QuantalX to expand its neurodiagnostic tool across Europe.
The Delphi-MD is a groundbreaking device that will be deployed in neurological care centres, neurology departments, and brain health networks. It enables early detection, differential diagnosis, and monitoring of neurological conditions such as stroke, Parkinson’s disease, dementia, Alzheimer’s disease, Normal Pressure Hydrocephalus (NPH), and more. The device is also designed to predict individual patients’ responses to treatment, offering healthcare professionals an objective and accessible method for neurodiagnosis.
As Europe’s aging population continues to grow, the incidence of neurodegenerative diseases is on the rise. According to the World Health Organization (WHO), there were 14.1 million people living with dementia in Europe as of 2019, with care costs reaching $439 billion (€389 billion). Parkinson’s disease, which is rapidly becoming one of the most common neurological disorders, currently affects over 1.2 million people in the region, a number that is set to increase as the population continues to age. The forecasted rise in the number of Europeans over 60 is expected to further strain healthcare systems, making advanced solutions for neurological care more crucial than ever.
Dr. Iftach Dolev, CEO and Co-founder of QuantalX, expressed his excitement about the achievement, stating: “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.”
The device, which offers a non-invasive, objective, and efficient approach to neurological assessment, has the potential to significantly improve patient outcomes. By enabling early detection of conditions such as Alzheimer’s and Parkinson’s, it promises to allow for better-tailored treatments and interventions, ultimately improving quality of life for patients. The Delphi-MD will not only help alleviate the burden of neurological diseases on patients and their families but also provide cost-saving opportunities for healthcare providers and reduce the strain on Europe’s healthcare systems.
The device’s CE MDR approval is a critical step in QuantalX’s efforts to scale its operations and bring advanced neurological care to more patients across Europe. With the growing need for innovative diagnostic solutions in brain health, the Delphi-MD is poised to play a pivotal role in addressing the challenges posed by neurological diseases in the region.
As QuantalX moves forward with the commercialization of Delphi-MD, the company remains focused on its mission to improve the quality and accessibility of brain health diagnostics, with plans to expand its reach in the coming months and years. The approval of this device further strengthens QuantalX’s commitment to advancing neurological care and improving patient outcomes on a global scale.
