QuantalX Joins FDA’s Total Life Cycle Advisory Program

QuantalX

QuantalX Neuroscience has some prestigious news.

The company announced that it will be part of FDA’s Total Life Cycle Advisory Program (TAP). In a press release,¹ QuantalX’s stated that its technology, the Delphi-MD Direct Electrophysiology Imaging, is the focus of the company’s entry into the program.

TAP is an FDA program that connects the participants with the federal agency, along with health insurers, healthcare organizations, and industry leaders. These groups collaborate to create a strategy for new technologies. To be accepted into the program, companies must show that their product benefits the general population.

The program is an advisory program designed to work with companies through the entire lifecycle of the new product. Collaborators will help to ensure regulatory compliance, market adoption, and enhanced positive patient impact.

In a press release, QuantalX co-founder and CEO Iftach Dolev, PhD., said, “The acceptance into the Total Life Cycle Advisory Program is a truly prestigious and significant opportunity for QuantalX. Collaborating with the leading healthcare market executives not only solidifies our commitment to neurodiagnosis excellence but also positions us for a stronger commercial entry into the market."

The Delphi-MD is a device capable of performing quick and accurate brain health assessments. It is a point-of-care device. It is used to detect early risk factors for dementia and stroke, while also being capable of early detection of Normal Pressure Hydrocephalus (NPH) disease. The data the device collects can also be used to determine how effective ventriculoperitoneal shunting will be on individual patients.

Dr. Rick Kuntz is president of Neuromodulation and chief medical and scientific officer at Medtronic. In the same press release, he said, “An NPH diagnostic test will become simple and accessible for the first time, and undetected and untreated patients will be able to benefit from an effective shunt (VPS) treatment."

Source

1. QuantalX Secures Spot in FDA's Prestigious Total Life Cycle Advisory Program (TAP). QuantalX. April 4, 2024. https://www.prnewswire.com/news-releases/quantalx-secures-spot-in-fdas-prestigious-total-life-cycle-advisory-program-tap-302108207.html