QuantalX Neuroscience's CE MDR Approval Transforms Brain Health Assessment Across Europe

QuantalX Neuroscience Receives CE MDR Approval



QuantalX Neuroscience Ltd. has made a significant advancement in brain health diagnostics by announcing the approval of its novel medical device, the Delphi-MD, under the new CE Medical Device Regulation (MDR) in the European Union. This certification embodies a rigorous standard in safety, efficacy, and quality, which QuantalX has successfully met, and it also highlights the company's dedication to pioneering solutions in neurological care.

The Delphi-MD device is set to transform the accessibility of neurodiagnostic assessments throughout Europe. With its recent approval, QuantalX plans to implement the device in various medical settings, including neurology departments, brain health networks, and specialized care centers. This implementation seeks to enhance brain health assessments, enabling early detection and accurate differential diagnosis for various brain disorders such as strokes, Parkinson's disease, Alzheimer's disease, and more. Furthermore, the Delphi-MD will assist in predicting how individual patients may respond to different treatment options, which is critical for personalized patient care.

As the population in Europe continues to age, the prevalence of neurodegenerative diseases such as dementia and Parkinson's is becoming increasingly pressing. The World Health Organization has reported that in 2019 alone, the economic impact of dementia care in Europe reached a staggering $439 billion, with an average cost of approximately $31,144 (€27,815) per patient. With over 1.2 million individuals affected by Parkinson's disease across the continent, the growing number of cases necessitates innovative and efficient healthcare solutions.

Dr. Iftach Dolev, CEO and Co-founder of QuantalX, emphasizes the importance of this CE MDR approval. He states, "The validation of our neurodiagnosis test represents an incredible milestone in our efforts to enhance brain health diagnostics. Our team's dedication to innovation is embodied in this approval, marking a new era for brain health diagnostics in Europe."

The launch of the Delphi-MD device not only promises to enhance early diagnosis and treatment outcomes but also aims to alleviate the financial pressures on healthcare systems that are grappling with the increasing burden of neurological conditions. By facilitating timely and precise detection of brain abnormalities, the device aims to improve patient quality of life significantly.

QuantalX Neuroscience is focused on fundamentally reshaping how brain health is assessed, thanks to its innovative Direct Neuro-Physiological technology utilized in the Delphi-MD device. This breakthrough now enables healthcare providers to implement more effective treatment strategies, ultimately enhancing care standards for patients residing in Europe.

In conclusion, QuantalX's CE MDR approval signifies an exciting step forward in neurodiagnostic technology, promising to deliver essential improvements in brain health assessments and marking a critical victory in the battle against debilitating neurological conditions in Europe.

For further information, media representatives can reach out to Adi Jacobson, VP Marketing at QuantalX Neuroscience, via email at [email protected] or by phone at +972502043934.

Topics Health)

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