US-based medical device company QuantalX Neuroscience has received the CE mark approval for its advanced brain health assessment device, Delphi-MD.
The approval was granted under the European Union’s (EU) new Medical Device Regulation (MDR).
Delphi-MD is designed to generate a high-resolution magnetic pulse that triggers a specific electro-physiological response in the brain network.
It can be used for assessing stroke, Parkinson’s disease, dementia, Alzheimer’s disease, and Normal Pressure Hydrocephalous (NPH) and predict the patients’ treatment response.
The device was granted the US Food and Drug Administration (FDA) breakthrough designation for early detection and differential diagnosis of brain disorders.
QuantalX said that its Delphi-MD will help improve brain health assessment and enable early detection and differential diagnosis of brain diseases.
Building on its ability to enable early detection and precise diagnosis of neurological disorders, Delphi-MD plays a key role in improving patient outcomes and quality of life.
Also, the device will address the growing economic and clinical burden on Europe’s healthcare systems, said QuantalX.
With CE mark approval, the medical device company is set to scale the marketing of its accessible and objective neurodiagnosis test across Europe.
QuantalX plans to deploy the Delphi-MD device in neurological care centres, neurology departments, and brain health networks.
QuantalX CEO and co-founder Iftach Dolev said: “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.”
