QuantalX Neuroscience has announced that its Delphi-MD (Direct Electrophysiological Imaging Device), an advanced neurodiagnostic platform designed for point-of-care use, has received clearance from the U.S. Food and Drug Administration (FDA).
The approval marks a significant step forward in the use of nerve stimulation for diagnostic purposes, positioning the Delphi-MD as a new standard in brain health evaluation.
The Delphi-MD platform supports the early and precise detection of brain abnormalities associated with conditions such as stroke, dementia (including Alzheimer’s, Lewy Body Disease, and vascular dementia), Parkinson’s disease, normal pressure hydrocephalus (NPH), traumatic brain injury (TBI), and general brain health.
The technology offers clinicians a non-invasive, radiation-free method to assess brain function, addressing critical gaps in neurological care. By enabling personalised, targeted treatments, the system aims to improve patient outcomes and overall quality of life.
The device has twice received FDA Breakthrough Designation Device status. The first designation recognised its potential for identifying patients at risk of stroke and dementia, while the second highlighted its role in detecting NPH and predicting responses to ventriculoperitoneal shunt (VPS) surgery.
It has also been selected for the FDA Total Product Life Cycle Advisory Programme (TAP), which supports its adoption within the US healthcare system. Additionally, the Delphi-MD brain health evaluation test has been assigned a dedicated CPT reimbursement code, simplifying its integration into clinical workflows.
QuantalX emphasises that the Delphi-MD platform represents a significant advancement in neurodiagnostic technology. Its user-friendly design provides healthcare providers with reliable insights, facilitating improved clinical decision-making.
The company is committed to expanding the applications of the Delphi-MD and collaborating with healthcare providers to transform neurodiagnostic practices and elevate standards of care.
Source: https://quantalx.com/quantalx-secures-fda-clearance-for-its-breakthrough-delphi-stimulator-advancing-direct-brain-health-diagnosis-at-the-point-of-care/
