Fda Grants Quantalx Breakthrough Designation For Diagnosing Normal Pressure Hydrocephalus And Predicting Treatment Response

The Delphi-MD device has been granted breakthrough designation technology status by the FDA for the diagnosis of Normal Pressure Hydrocephalus (NPH) patients and the prediction of their response to ventriculoperitoneal shunting surgery (VPS) treatment. QuantalX, the developer of the Delphi-MD neurodiagnostic device, has announced the prestigious FDA breakthrough designation medical device status for NPH diagnosis and treatment prediction. The FDA recognizes the device's innovative value in accurately diagnosing NPH patients and predicting their response to the recommended VPS surgery.

NPH is a condition characterized by disrupted cerebrospinal fluid (CSF) dynamics, leading to difficulties in walking, balancing, urinary function, and cognitive decline. However, NPH is often underdiagnosed due to the invasive and inaccessible nature of the diagnostic procedure. It can be misdiagnosed as other forms of dementia or movement disorders such as Alzheimer's disease, vascular dementia, or Parkinson's disease. Nevertheless, NPH can be effectively treated, especially when detected early, through the implantation of a ventriculoperitoneal shunt.

The current diagnostic procedure for NPH involves a complex assessment, including cognitive evaluation, brain imaging, and an invasive spinal CSF withdrawal test. This procedure requires specialized expertise, dedicated facilities, and carries a significant risk of complications. Moreover, it fails to reliably identify the patients who would benefit most from VPS surgery.

Despite the effectiveness of VPS surgery in treating NPH, the complex diagnostic procedure remains a major barrier to accurate diagnosis. As a result, only a small percentage of affected patients undergo shunt surgery.

The Delphi-MD system is an innovative medical device that provides accessible neurodiagnostic capabilities at any point of care, leading to improved brain health outcomes and better patient care. The FDA granted breakthrough designation to Delphi-MD based on preliminary clinical data demonstrating its superiority over the current standard-of-care diagnostic procedure in accurately diagnosing NPH and predicting the effectiveness of shunt treatment.

This marks the second time that the Delphi-MD device has received a breakthrough designation medical device status from the FDA. In June 2021, it was granted this status for its ability to detect patients at risk for dementia and stroke, enabling the early identification of brain abnormalities indicating the progression to stroke and dementia. Today's announcement significantly expands the value delivered by Delphi-MD to healthcare professionals and patients alike. It provides an accurate and clinically objective measurement system for neuronal function, streamlining the diagnosis process, improving treatment selection, enabling earlier intervention, and ultimately enhancing the quality of life for those affected by NPH.

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