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QuantalX's Delphi Stimulator Receives FDA Clearance for Advancing Brain Health Diagnosis

• QuantalX has received FDA clearance for its Delphi stimulator, a novel device designed for direct brain health diagnosis at the point of care. • The Delphi-MD platform enables early detection of brain abnormalities across conditions like stroke, dementia, Parkinson's Disease, and traumatic brain injury. • Delphi-MD, which has received two FDA Breakthrough Device designations, offers non-invasive insights into brain function, supporting precision treatments. • The Delphi-MD brain health evaluation test has already obtained a dedicated CPT reimbursement code (0858T), facilitating its adoption in the US healthcare market.

QuantalX has announced that its Delphi stimulator has received FDA clearance, marking a significant advancement in direct brain health diagnosis. The Delphi-MD platform offers clinicians a non-invasive, radiation-free method for the early detection of brain abnormalities across a range of neurological conditions.
The Delphi-MD platform is designed to detect brain abnormalities associated with stroke, various forms of dementia (including Alzheimer's, Lewy Body Disease, and Vascular Dementia), Parkinson's Disease, Normal Pressure Hydrocephalus (NPH), and Traumatic Brain Injury (TBI). This technology aims to provide objective insights into brain function, supporting tailored treatments and enhancing patient outcomes.

FDA Designations and Clinical Impact

Delphi-MD has been granted FDA Breakthrough Device designation twice, initially for detecting patients at risk for stroke and dementia, and subsequently for detecting NPH and predicting treatment response to ventriculoperitoneal shunt (VPS) surgery. The platform was also selected for the FDA Total Product Life Cycle Advisory program (TAP), supporting its integration into the US healthcare system. The Delphi-MD brain health evaluation test has secured a dedicated CPT reimbursement code (0858T).

Executive Perspective

"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."

About Delphi-MD Technology

Delphi-MD is designed as a user-friendly tool for healthcare providers, offering reliable insights to support improved care decisions. QuantalX plans to continue working with healthcare providers to expand the applicational use of Delphi-MD, aiming for a transformative impact on neurodiagnostic practices.
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Reference News

[1]
QuantalX Secures FDA Clearance for its breakthrough Delphi stimulator, advancing direct ...
prnewswire.com · Nov 12, 2024

Delphi-MD platform detects brain abnormalities early, including stroke, dementia, Parkinson's, NPH, TBI, and assesses br...

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