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.

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.