The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to Blue Arbor Technologies’ Restore Neuromuscular Interface System for people with upper-limb loss. The system has also been accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot.
Blue Arbor Technologies, a company developing novel neuromuscular interfaces and robotic prosthetic control systems for people with limb loss, designed the product to integrate the peripheral nervous system with commercially available robotic prostheses to restore naturalistic hand and arm function.
Unlike current interface technologies that are dependent on surface skin electrodes, the Restore System is designed to provide a direct connection to the patient’s residual muscles and peripheral nerves to deliver reliable, voluntary movement control signals. In addition, it allows for simultaneous and independent movement of finger, wrist, and elbow joints, and has been shown to consistently capture motor signals for over five years in early feasibility human trials.
The FDA Breakthrough Devices Program expedites the development, assessment, and review process for medical devices that provide more effective treatment options for patients with life-threatening or irreversibly debilitating diseases or conditions. It is designed to ensure that patients and healthcare providers have more timely access to these novel, new medical devices. The TAP Pilot is intended to help streamline collaboration between the FDA and medical device sponsors to accelerate the development and path to commercialization of innovative devices in the breakthrough program.
“Blue Arbor Technologies is dedicated to developing solutions that address the unmet need for improved robotic prosthetic control options for people with limb loss so they can more easily integrate a prothesis in their daily lives and return to normality,” said Paul Cederna, MD, president of Blue Arbor Technologies. “The Breakthrough Designation and TAP enrollment is a valuable step in the pathway to FDA market clearance. We look forward to working closely with the agency to make the Restore System available to people with upper-limb loss to hopefully increase prosthesis adoption and use.”
