Blue Arbor Technologies has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its RESTORE System for people with upper limb loss.

RESTORE is an investigational neuroprosthetic interface designed to detect voluntary nerve and muscle control signals to facilitate the function of upper limb prosthetics.

It is designed to easily integrate the peripheral nervous system with commercial robotic prosthetics to restore naturalistic hand and arm function in patients with upper limb loss.

According to the company, its platform enables patients to move their upper limb prosthetic devices with superior dexterity, agility, and reliability.

In addition, the US regulator has accepted the RESTORE Interface System into its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.

The pilot is intended to support collaboration between the FDA and medical device sponsors to advance the development and commercialisation of devices in the breakthrough program.

Blue Arbor Technologies president Paul Cederna said: “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.

“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.”

Unlike current technologies that depend on surface skin electrodes, the RESTORE System provides a direct connection to the patient’s residual muscles and peripheral nerves.

The direct connection is said to provide superior control of currently available advanced robotic prostheses, delivering reliable, voluntary movement control signals.

The RESTORE System can be implanted at the time of an amputation or at the time of any upper limb reconstructive surgery for the treatment.

It facilitates simultaneous and independent movement of finger, wrist, and elbow joints, which is not possible with surface skin electrodes.

According to the robotic prosthetics company, the system has been shown to consistently capture motor signals for over five years in early feasibility human trials.