Blue Arbor Technologies Secures FDA Breakthrough Device Designation and TAP Enrollment for RESTORE™ Neuromuscular Interface System

Thursday, April 25, 2024

Blue Arbor Technologies has achieved a significant milestone in its mission to revolutionize prosthetic control systems with the announcement of FDA Breakthrough Device Designation for the RESTORE™ Neuromuscular Interface System.

This breakthrough designation, along with acceptance into the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, marks a pivotal step forward in advancing upper limb prosthetic technology.

The Restore System, developed by Blue Arbor Technologies, aims to seamlessly integrate the peripheral nervous system with existing robotic prosthetics, offering a novel solution for individuals with upper limb loss. Unlike conventional interface technologies reliant on surface skin electrodes, RESTORE establishes a direct connection to residual muscles and peripheral nerves, enabling reliable and intuitive control signals for prosthetic movement.

This direct interface not only enhances control but also facilitates simultaneous and independent movement of finger, wrist, and elbow joints, surpassing current capabilities.

Medical experts are optimistic about the transformative potential of the RESTORE System.

Despite technological advancements, a substantial percentage of individuals with upper limb loss abandon their prostheses due to issues such as discomfort, heaviness, and limited functionality.

Blue Arbor Technologies is committed to addressing these challenges and improving the quality of life for individuals with limb loss.Emphasizes their dedication to developing solutions that facilitate prosthesis integration and enhance daily functionality.

The Breakthrough Designation and TAP enrollment represent significant milestones on the path to FDA market clearance, signaling a collaborative effort between the company and regulatory authorities to expedite access to innovative medical devices.

The FDA's Breakthrough Devices Program aims to accelerate the development and review process for devices addressing life-threatening or debilitating conditions, ensuring timely access for patients and healthcare providers. The TAP Pilot further streamlines collaboration between the FDA and device sponsors, fostering innovation and expediting the path to commercialization.

Restore Neuromuscular Interface System holds promise as a transformative solution for individuals with upper limb loss, offering enhanced control, functionality, and integration into daily life.


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