QuantalX Neuroscience Achieves CE MDR Approval for Delphi-MD Brain Health Device in EU

QuantalX Neuroscience Receives CE MDR Approval for Delphi-MD Device



QuantalX Neuroscience Ltd. has proudly announced that it has received the CE MDR approval for its groundbreaking brain health assessment device, Delphi-MD. This significant milestone allows for the commercialization of the device across the European Union, greatly enhancing the capability for early detection and diagnosis of various neurological conditions.

Impact on European Healthcare


The approval opens avenues for deploying the Delphi-MD device in neurological care centers, neurology departments, and brain health networks throughout Europe. The innovative technology aims to facilitate accurate assessments of brain health, enabling timely identification and differential diagnosis of conditions such as strokes, Parkinson's disease, dementia, Alzheimer's disease, and normal pressure hydrocephalus (NPH), among others. Moreover, it predicts patient treatment responses, contributing to personalized healthcare.

As Europe's population ages, the incidence of neurodegenerative diseases including dementia, Parkinson's, and strokes is on the rise. The World Health Organization (WHO) reported in 2019 that managing the 14.1 million people affected by dementia in Europe would cost an estimated $439 billion, averaging $31,144 (27,815 euros) per patient. Additionally, Parkinson’s disease, identified as the fastest-growing neurological condition, currently impacts over 1.2 million individuals in Europe, with projections indicating a substantial increase as the population ages. By 2050, the number of Europeans aged 60 and over is expected to rise dramatically, putting further strain on healthcare systems and underscoring the urgent demand for advanced care solutions.

A Step Forward in Neurological Excellence


Dr. Iftach Dolev, CEO and co-founder of QuantalX, shared his thoughts on this historic achievement: “The CE MDR approval validates the unparalleled innovation underlying our neurodiagnostic test. It demonstrates our team’s dedication and marks the beginning of a new era in brain health diagnostics.” With the potential for early detection and accurate diagnosis of neurological disorders, the Delphi-MD promises to significantly enhance patient outcomes and quality of life while alleviating the growing economic and clinical burdens on European healthcare systems.

About QuantalX Neuroscience


QuantalX is committed to fundamentally improving patient care through objective, precise early detection and differential diagnosis of brain anomalies via its novel neurophysiological technology, embodied in the Delphi-MD device. This innovative solution represents a leap forward in providing better care for patients suffering from neurological conditions.

For media inquiries, please contact:
Adi Jacobson
VP Marketing, QuantalX Neuroscience
Email: [email protected]
Phone: +972502043934

Image of Delphi-MD

Topics Health)

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