QuantalX Neuroscience has been chosen by the FDA for the Total Life Cycle Advisory Program, recognizing their Delphi-MD medical device's ability to detect Normal Pressure Hydrocephalus (NPH) disease and predict patients' response to ventriculoperitoneal shunting (VPS) surgery. This program aims to develop a comprehensive strategy for technologies that benefit the general population.
QuantalX Neuroscience: Revolutionizing Early Detection of Brain Disorders
( Credit to: Prnewswire )
QuantalX Neuroscience, a healthcare company dedicated to early detection of brain disorders, has been selected by the U.S. Food and Drug Administration (FDA) for the Total Life Cycle Advisory Program (TAP). This program brings together the FDA, major health insurers, healthcare organizations, and industry leaders to develop a comprehensive strategy for technologies that can benefit the general population.
With a commitment to neurodiagnosis excellence, QuantalX has been recognized for their innovative Delphi-MD medical device. Utilizing Direct Electrophysiology Imaging technology, Delphi-MD is able to detect Normal Pressure Hydrocephalus (NPH) disease and predict patients' response to ventriculoperitoneal shunting (VPS) surgery. NPH is a type of dementia characterized by a movement disorder, and VPS surgery helps relieve pressure buildup in the brain cavities, delaying disease progression and improving patients' health.
Advancing Neurodiagnosis with Delphi-MD: Breakthrough Designation Technology
QuantalX's Delphi-MD medical device has already received Breakthrough Designation Technology status from the FDA for its ability to identify patients at risk of dementia and stroke, as well as diagnose NPH and predict treatment response. This objective and automated approach allows for quick and accurate brain health assessments at the point-of-care.
By reducing misdiagnosis rates and care costs while enhancing patient well-being, Delphi-MD's collaborative care model provides personalized treatment and improves patient outcomes. With its novel Direct Neuro-Physiological technology, Delphi-MD aims to revolutionize the early detection and differential diagnosis of brain abnormalities.
Total Life Cycle Advisory Program: Accelerating Market Entry and Growth
The acceptance into the Total Life Cycle Advisory Program is a significant opportunity for QuantalX. This program aims to guide innovative technologies, like Delphi-MD, through the entire product life cycle, ensuring regulatory compliance, market adoption, and positive patient impact.
Participating in this program will allow QuantalX to accelerate its market entry and establish a strong foundation for future growth. With the support and collaboration of leading healthcare market executives, QuantalX is well-positioned to make a positive impact in the field of brain disorder detection and treatment.