QuantalX, the developer of the Delphi-MD neurodiagnostic device, has recently announced that the FDA has awarded it breakthrough designation status. This prestigious designation has been granted for the device's application in diagnosing patients with Normal Pressure Hydrocephalus (NPH) and predicting their response to ventriculoperitoneal shunting (VPS) surgery, which is a highly effective treatment option.
NPH is a condition characterized by disruptions in cerebrospinal fluid dynamics, leading to symptoms such as difficulties in walking, urinary issues, and cognitive decline. However, NPH often goes undetected due to the invasive and complex nature of current diagnostic procedures. This leads to underdiagnosis and delayed treatment. The Delphi-MD device offers a novel point-of-care solution for neurodiagnostics, aiming to address these challenges.
The FDA's breakthrough designation recognizes the innovative value of the Delphi-MD device in accurately diagnosing NPH patients and predicting the effectiveness of VPS surgery. The device provides accessible and reliable measurements, surpassing the current standard-of-care diagnostic procedure. By streamlining the diagnostic process, the Delphi-MD device offers an improved approach for identifying patients who would benefit most from VPS surgery.
The breakthrough designation is a significant milestone for QuantalX and the Delphi-MD device. This is the second time the device has received such recognition from the FDA, with the previous designation granted for its ability to detect patients at risk for dementia and stroke. The availability of this breakthrough technology expands its value for both healthcare professionals and patients, revolutionizing the diagnosis and treatment response prediction for NPH.
By providing an accessible and advanced neurodiagnostic tool, the Delphi-MD device has the potential to enhance patient care, enable earlier intervention, and improve the quality of life for individuals with NPH.
