QuantalX Secures Spot in FDA's Prestigious Total Life Cycle Advisory Program (TAP)
NEW YORK, April 4, 2024 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA). The program will focus on advancing Delphi-MD's unique Direct Electrophysiology Imaging technology, enabling the early detection of Normal Pressure Hydrocephalus (NPH) disease, with high accuracy rates, and the prediction of patients' response to ventriculoperitoneal shunting (VPS). The TAP program brings together the FDA, major health insurers, healthcare organizations, and industry leaders in a collaborative effort to construct a comprehensive strategy for technologies that can benefit the general population. This strategic framework spans crucial elements, such as value creation in the U.S. market, meticulous preparation for regulatory approval, meaningful engagement with insurers, and the establishment of a robust market presence with customers.
- NEW YORK, April 4, 2024 /PRNewswire/ -- QuantalX Neuroscience, a pioneering healthcare company dedicated to early detection of brain disorders using the Delphi-MD medical device, announced today its selection to participate in the highly prestigious Total Life Cycle Advisory Program (TAP) initiated by the U.S. Food and Drug Administration (FDA).
- "The acceptance into the Total Life Cycle Advisory Program is a truly prestigious and significant opportunity for QuantalX," remarked Iftach Dolev.
- The Total Life Cycle Advisory Program aims to guide innovative technologies through the entire product life cycle, ensuring regulatory compliance, market adoption, and enhanced positive patient impact.
- The valuable experience and insights within this program are expected to accelerate QuantalX's market entry and establish a solid foundation for future growth.