MedTech Dive November 22, 2021
FDA has awarded breakthrough device designations to two futuristic devices, granting the regulatory privileges to Blackrock Neurotech’s brain-computer interface (BCI) and an exo-suit from ReWalk Robotics’ intended to help stroke patients walk.
Blackrock landed the breakthrough status for MoveAgain, a BCI system designed to enable immobile patients to control a mouse cursor, keyboard, mobile device, wheelchair or prosthetic device using their brains. The device features an array that is implanted in the patient’s brain to decode intended movement neuronal activity. The decoded signals are sent to an external device such as a wheelchair to enable the immobile patient to control their external environment.
Buoyed by the breakthrough designation, Blackrock is aiming to commercialize the device next year. The target...
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