The Delphi-MD (Direct Electrophysiological Imaging Device), a point-of-care neurodiagnostic platform, has received clearance from the U.S. Food and Drug Administration (FDA) for its Delphi stimulator, designed specifically for the nerve stimulation for diagnostic purposes.
The device, developed by QuantalX Neuroscience, enables accurate, early detection of brain abnormalities across a wide range of conditions, including stroke, dementia, Parkinson’s Disease, Normal Pressure Hydrocephalus (NPH), Traumatic Brain Injury (TBI), and general brain health assessment.
By addressing critical gaps in neurological care, Delphi-MD provides clinicians with non-invasive, radiation-free insights into brain function—a first in healthcare. This approach supports precision-tailored treatments, enhancing both patient outcomes and quality of life.
Delphi-MD was granted FDA Breakthrough Designation Device status twice, the first for the detection of patients at risk for stroke and dementia and the second for detection of NPH and prediction of treatment response to ventriculoperitoneal shunt (VPS) surgery.
Delphi-MD was also selected for the prestigious FDA Total Product Life Cycle Advisory program (TAP). Delphi-MD brain health evaluation test has already obtained a dedicated CPT reimbursement code.
“We are thrilled to announce this FDA clearance for our Delphi stimulator” said Iftach Dolev PhD, CEO and Co-Founder of QuantalX.
“This is a significant step forward in our path to revolutionising the world of neurodiagnostics, allowing us to make a lasting impact on brain health and elevate standards in patient care as we accelerate our US market penetration.
“Our team remains committed to pioneering innovations that advance medical science and deliver game-changing solutions for clinicians and patients alike.”
