Blue Arbor’s RESTORE Neuromuscular Interface System Receives FDA Breakthrough Device Designation & TAP Enrolment

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US FDA granted BTD designation to Blue Arbor’s RESTORE Neuromuscular Interface System and accepted for Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot (enables FDA and medical device sponsors collaboration to accelerate development and commercialization of innovative devices in breakthrough program)
RESTORE, a Robotic Prosthetic control system that creates effortless coordination between the Patient’s Residual muscles and Nervous system to prosthetic upper limbs to reinstate the natural function of the arm
The device enables independent movement of wrist, arms, and elbow joints surpassing surface skin electrodes; constant motor signal captured over past 5 yrs in early feasibility human trials

Ref: Blue Arbor | Image: Blue Arbor

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