Quantalx Secures Fda Breakthrough Designation For Normal Pressure Hydrocephalus Diagnosis And Treatment Response Prediction
QuantalX, the developer of the Delphi-MD neurodiagnostic device, has received a prestigious FDA breakthrough designation for its innovative technology in diagnosing Normal Pressure Hydrocephalus (NPH) and predicting the response to ventriculoperitoneal shunting surgery (VPS) treatment. NPH is a condition characterized by disturbances in cerebrospinal fluid dynamics, leading to difficulties in walking, urinary problems, and cognitive decline.
The FDA recognition acknowledges the significant value of the Delphi-MD device in accurately diagnosing NPH patients and determining their suitability for VPS surgery, an important treatment for NPH. Current diagnostic procedures for NPH are often invasive and complex, resulting in under-detection of the condition. Misdiagnosis is common as NPH symptoms can be mistaken for other neurodegenerative disorders, underscoring the need for accurate diagnosis to ensure appropriate interventions.
The Delphi-MD system addresses these challenges by offering a point-of-care neurodiagnostic solution that is accessible and user-friendly. Through advanced technology, it demonstrates superior performance compared to traditional diagnostic methods, enabling accurate NPH diagnosis and prediction of treatment response to VPS surgery. This breakthrough designation signifies a significant advancement in the field, streamlining the diagnostic process and facilitating timely interventions for improved patient outcomes.
This FDA breakthrough designation for the Delphi-MD device follows a previous designation received in 2021 for its ability to detect patients at risk for dementia and stroke. The inclusion of NPH diagnosis and treatment response prediction expands the device's capabilities, providing clinicians with a comprehensive tool to identify functional and structural brain abnormalities associated with both NPH and the early progression of stroke and dementia.
The recognition of the Delphi-MD device's breakthrough status underscores its importance in enhancing the diagnosis and treatment of NPH. By simplifying the diagnostic process, enabling accurate predictions of treatment response, and ultimately improving patient quality of life, the device represents a significant advancement in neurodiagnostics and patient care.