QuantalX Neuroscience has gained the European CE Medical Device Regulation (MDR) approval for the Delphi-MD, a device for assessing brain health.

With this certification in place, the company is poised to expand the reach of the device that is claimed to be the first to offer direct brain network visualisation technology.

It is set for deployment in various neurological care settings, including neurology departments and brain health networks throughout Europe.

QuantalX CEO and co-founder Dr 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.”

Delphi-MD operates by generating a “high-resolution” magnetic pulse that elicits an electro-physiological response from specific brain networks.

The response signature of a person may be similar in healthy brains, but it may vary in pathological states, allowing for “highly accurate” neurodiagnostic assessments and treatment predictions for a range of brain health conditions.

The device offers differential diagnosis and early identification of abnormalities of the brain such as Parkinson's, Alzheimer’s, normal pressure hydrocephalous (NPH), dementia, and stroke. It also predicts individual treatment responses.

Delphi-MD will help improve patient outcomes and quality of life while reducing the economic and clinical strain on healthcare systems in Europe.

In May 2023, the device received the breakthrough designation technology status from the US Food and Drug Administration (FDA) for use in NPH diagnosis as well as prediction of response to ventriculoperitoneal shunting surgery (VPS) treatment.

QuantalX's technology is said to offer objective, accurate, and early identification of brain abnormalities.