Phantom Neuro received the Breakthrough Device designation and the Targeted Acceleration Pathway (TAP) designation from the US Food and Drug Administration (FDA) for its flagship technology, Phantom X. Phantom X is a minimally invasive neural interface platform that provides intuitive control of prosthetic and robotic devices. It can be implanted just beneath the skin through an outpatient procedure.
Breakthrough Device designation recognizes a company’s potential to provide advantages over existing solutions for individuals with function-limiting injuries. The TAP designation facilitates early and strategic communication with the FDA, streamlining the path to commercialization. The designations expedite Phantom Neuro’s development and regulatory review process.
“Receiving both of these certified designations from the FDA is a tremendous validation of our work,” said Connor Glass, MD, Phantom Neuro founder and CEO. “These recognitions validate our technology and reflect our commitment to creating scalable, real-world solutions that restore functionality and independence to amputees and those with functional disabilities. Our goal is to bring Phantom X to patients faster, and achievements like this accelerate our clinical and regulatory processes.”
