RESTORE Neuroprosthetic Gets FDA Breakthrough Nod

Image credit: Blue Arbor Technologies

US-based Blue Arbor Technologies has announced Breakthrough Device designation from the Food and Drug Administration (FDA) for its RESTORE Neuromuscular Interface System for people with upper limb loss.

A neuroprosthetic interface, RESTORE is designed to integrate the peripheral nervous system with robotic prosthetics, to give patients back the naturalistic use of upper limbs with “unprecedented dexterity, speed, and reliability”.

The system has also secured a place with the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot, which facilitates streamlined communication between the FDA and medical device innovators under the Breakthrough Device 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 Blue Arbor Technologies’ President, Dr Paul Cederna.

“The Breakthrough Designation and TAP enrollment is a valuable step in the pathway to FDA market clearance.”

Check out the this video from Blue Arbor Technologies to see the RESTORE system in action, or refer to the press release for more details.