QuantalX Secures FDA Clearance For Its Breakthrough Delphi Stimulator, Advancing Direct Brain Health Diagnosis At The Point Of Care
(NYC, Nov 11) – QuantalX Neuroscience Ltd. is proud to announce that its Delphi stimulator has received clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking nerve stimulation capabilities. This important milestone advances Delphi-MD going into the market as a new standard in brain health evaluation by enabling objective, personalized treatment options.
The Delphi-MD (Direct Electrophysiological Imaging) platform enables accurate, early detection of brain abnormalities across a wide range of conditions, including stroke, dementia (Alzheimer’s, Lewy Body Disease, Vascular 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 transformative 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), supporting the company’s efforts to advance the successful adoption of the technology in the US healthcare market. The Delphi-MD brain health evaluation test has already obtained a dedicated CPT reimbursement code (0858T).
“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 revolutionizing 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.”
Delphi-MD represents a leap in neurodiagnostic technology, offering an objective, user-friendly tool for healthcare providers seeking reliable insights to support improved care decisions. As part of its ongoing commitment to advancing neurological health, QuantalX will continue working closely with healthcare providers to expand Delphi-MD’s applicational use, ensuring a transformative impact on neurodiagnostic practices.
About QuantalX Neuroscience
QuantalX is committed to fundamentally improving patient care and alleviating the burden on healthcare systems through objective and accurate, early detection and differential diagnosis of brain abnormalities, leveraging its novel Direct Neuro-Physiological technology, the Delphi-MD device.
Media Contact:
Adi Jacobson
VP Marketing, QuantalX Neuroscience
Adi@quantalx.com
Tel: +972502043934