Phantom Neuro, the neurotech company advancing human-machine interface, announces today that it has received two prestigious designations from the U.S. Food and Drug Administration (FDA); both the Breakthrough Device Designation and the highly selective TAP (Targeted Acceleration Pathway) Designation for its minimally invasive neural interface Phantom X platform.
These designations advance Phantom Neuro’s mission to pioneer the future of human capability through peripheral neural interface technology, allowing complex electronic systems, such as prosthetic limbs, to function as natural extensions of the human body.
The FDA’s Breakthrough Device Designation recognizes Phantom Neuro’s potential to provide significant advantages over existing solutions for individuals with function-limiting injuries. The TAP Designation, an even more selective recognition within the FDA’s Medical Device Accelerator program, facilitates early and strategic communication with the agency, streamlining the path to commercialization. These designations expedite Phantom Neuro’s development and regulatory review process, helping the company bring its transformative technology to market faster and improve patient outcomes.
Phantom Neuro’s flagship technology, Phantom X, is a minimally invasive neural interface providing intuitive control of prosthetics and robotic devices. Phantom X is designed to be implanted just beneath the skin through a simple outpatient procedure, accessible by over 70,000 qualified surgeons nationwide. The platform uses sophisticated algorithms to decode natural human movement, providing a seamless, near-human experience when controlling prosthetic limbs and assistive technologies.
“Receiving both of these certified designations from the FDA is a tremendous validation of our work,” said Dr. Connor Glass, Founder and CEO of Phantom Neuro. “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.”
Phantom Neuro’s technology is redefining what’s possible for individuals with limb loss and severe mobility impairments, offering renewed independence and an improved quality of life. Building on the success of its recent ASCENT study (linked here), demonstrating that the Phantom X platform achieved an unprecedented 94% accuracy in decoding real-time gestures across 11 essential hand and wrist movements, the company is advancing its clinical development with additional trials in 2025.
