#USA #New York #QuantalX #Delphi-MD #Neurodiagnostics

Introduction

QuantalX Neuroscience Ltd. has recently achieved a significant milestone with the CE MDR approval of its pioneering device, the Delphi-MD, designed to assess brain health. This approval allows for the commercialization of the Delphi-MD in the European market, establishing a new standard for neurological diagnostics.

What is the Delphi-MD?

The Delphi-MD device is a neurodiagnostic tool that offers an objective and accessible assessment of brain health. It is particularly valuable in neurological care settings, including medical centers, expert referrals, and brain health networks. The device enables early detection and differential diagnosis of several neurological disorders, including strokes, Parkinson's disease, dementia, and more. With this technology, healthcare providers can better predict how individual patients may respond to treatments, making personalized medicine a reality.

Rising Need for Brain Health Solutions

Europe is currently facing a surge in neurodegenerative diseases, largely due to its aging population. According to the World Health Organization (WHO), the total cost of caring for the 14.1 million dementia patients in Europe reached $439 billion in 2019, averaging $31,144 (about €27,815) per patient. Moreover, with over 1.2 million affected individuals, Parkinson's disease is the fastest growing neurological condition in the region. As populations age, the number of patients over 60 is expected to soar, stressing healthcare systems and emphasizing the necessity for advanced diagnostic solutions like Delphi-MD.

Insights from Leadership

Dr. Iftach Dolev, CEO and co-founder of QuantalX, expressed his enthusiasm regarding the CE MDR certification. He stated, "The CE MDR approval confirms the unprecedented innovation that underlies our neurodiagnostic test. It is a testament to our team's dedication and marks the beginning of a new era in brain health diagnostics." Dr. Dolev also highlighted that with its capacity to enable early detection and accurate diagnostics of neurological diseases, the Delphi-MD will play a vital role in improving patients' treatment outcomes and quality of life, while helping mitigate the growing burden on European healthcare systems.

The Future of Neurological Care

QuantalX Neuroscience remains committed to improving patient care and relieving health systems through its innovative Delphi-MD technology. As the demand for effective solutions in the realm of brain health escalates, this groundbreaking device promises to significantly enhance the quality of neurological assessments and, subsequently, patient care across Europe.

Conclusion

The approval of the Delphi-MD by QuantalX Neuroscience not only opens avenues for availability in the EU but also sets a benchmark for safety, effectiveness, and quality in the medical device sector under the new EU Medical Device Regulation (MDR). As the landscape of neurological care evolves, this device stands at the forefront, ready to make a lasting impact on healthcare in Europe and beyond.