Accessibility Statement Skip Navigation
  • Back to Global Sites
  • +972-77-2005042
  • Blog
  • Journalists
  • GDPR
  • Send a Release
PR Newswire: news distribution, targeting and monitoring
  • News
  • Products
  • Contact
  • Hamburger menu
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • Telephone

    • +972-77-2005042 from 8 AM - 11 PM IL

    • Contact
    • Contact

      +972-77-2005042
      from 8 AM - 11 PM IL

  • Request More Information
  • Journalists
  • GDPR
  • Request More Information
  • Journalists
  • GDPR
  • Request More Information
  • Journalists
  • GDPR
  • Request More Information
  • Journalists
  • GDPR

QuantalX Neuroscience Announces CE MDR Approval, Making Brain Health Assessment Available in the EU
  • USA - English
  • USA - Français
  • USA - Deutsch


News provided by

QuantalX

12 Feb, 2025, 10:00 IST

Share this article

Share toX

Share this article

Share toX

The company announces CE MDR approval for its novel Delphi-MD neurodiagnosis medical device in preparation for EU commercialization, improving patients' clinical outcomes and well being while reducing healthcare systems and payors' financial burden.

NEW YORK, Feb. 12, 2025 /PRNewswire/ -- QuantalX Neuroscience Ltd. is proud to announce that its groundbreaking brain health assessment device, the Delphi-MD, has received CE MDR approval, the European Union's certification under the new Medical Device Regulation (MDR). The CE MDR certification process sets a new benchmark for safety, efficacy, and quality in medical devices. This achievement underscores QuantalX's commitment to innovation and excellence in neurological care.

Delphi-MD Makes Brain Health More Accessible in Europe
Delphi-MD Makes Brain Health More Accessible in Europe

With CE MDR approval, QuantalX is set to scale the commercialization of its accessible and objective neurodiagnosis test across Europe. The Delphi-MD device will be deployed in neurological care centers, neurology departments, and brain health networks. Delphi-MD will streamline improved brain health assessment, early detection and differential diagnosis of any brain abnormality or disease such as stroke, Parkinson disease, dementia, Alzheimer's disease, Normal Pressure Hydrocephalous (NPH) and more, as well as prediction of individual patients' treatment response.

The aging population in Europe is driving a sharp rise in neurodegenerative diseases such as dementia, Parkinson's, and stroke. According to the World Health Organization (WHO), caring for the 14.1 million people living with dementia in Europe cost $439 billion in 2019, averaging $31,144 (€27,815) per patient. Parkinson's disease, the fastest-growing neurological disorder, affects over 1.2 million people across Europe, with cases expected to rise as the population ages. By 2050, the number of Europeans aged 60 and older is projected to increase significantly, further straining healthcare systems and highlighting the urgent need for advanced care solutions.

Dr. Iftach Dolev, CEO and Co-founder of QuantalX, shared his thoughts on this landmark achievement: "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."

With its ability to enable early detection and precise diagnosis of neurological disorders, Delphi-MD will play a crucial role in improving patient outcomes and quality of life while alleviating the growing economic and clinical burden on Europe's healthcare systems.

About QuantalX Neuroscience

QuantalX is committed to fundamentally improving patient care and alleviating the burden on healthcare systems through objective and accurate, early detection and differential diagnosis of brain abnormalities, leveraging its novel Direct Neuro-Physiological technology, the Delphi-MD device.

Media Contact:
Adi Jacobson
VP Marketing, QuantalX Neuroscience
[email protected]
Tel: +972502043934

Photo - https://mma.prnewswire.com/media/2617703/QuantalX_Delphi_MD.jpg

SOURCE QuantalX

Modal title

Also from this source

QuantalX Receives FDA De Novo Clearance for Delphi-MD, Establishing a New Modality of Brain Function Assessment

QuantalX Receives FDA De Novo Clearance for Delphi-MD, Establishing a New Modality of Brain Function Assessment

QuantalX Neuroscience today announced that its Delphi-MDTM System, a first-of-its-kind functional neuro-imaging (FNI) device, has been granted FDA de ...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Medical Equipment

Medical Equipment

European Government

European Government

News Releases in Similar Topics

Contact PR Newswire

  • +972-77-2005042
    from 8 AM - 11 PM IL

Global Sites

  • APAC
  • APAC - Traditional Chinese
  • Asia
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany

 

  • India
  • Indonesia
  • Israel
  • Italy
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland

 

  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom
  • United States

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921
Global Sites
  • Asia
  • Brazil
  • Canada
  • Csezh
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Israel
  • Italie
  • Mexico
  • Middle East
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom
  • United States
+972-77-2005042
from 8 AM - 11 PM IL
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • Cookie Settings
Copyright © 2025 Cision US Inc.