FDA Grants Breakthrough Recognition for Blackrock Neurotech’s Brain-Computer Interface

The Utah Array Platform [Image from Blackrock Neurotech/ClearPoint Neuro]

Blackrock Neurotech announced that it has received the FDA’s breakthrough device designation for its MoveAgain brain-computer interface system (BCI).

Salt Lake City-based Blackrock Neurotech developed its MoveAgain BCI system to give immobile patients the ability to control a mouse pointer, keyboard, mobile device / tablet, wheelchair or prosthesis by just thinking, according to a press release .

The company said the results of its portable MoveAgain BCI could include improved mobility and independence, leading to return to work, participation in recreational activities, and more effective and faster communication.

MoveAgain BCI contains an array implanted in the brain that decodes movements from neural activity. The signals are then wirelessly transmitted to an external device, such as a cursor or a wheelchair, giving people control over their surroundings.

“We look forward to working closely with the FDA to prioritize the development of the MoveAgain brain-computer interface system, which brings us closer to our goal of commercialization in 2022,” said Marcus Gerhardt, Co-Founder and CEO of Blackrock Neurotech, in the press release. “Patients with quadriplegia are desperate to have access, and we are committed to promoting their ability to increase their independence with our BCI technology.”

Blackrock Neurotech Chairman and President Florian Solzbacher added that the company believes it has sufficient safety and effectiveness data to support early applications, while large-scale integration technologies have enabled further miniaturization during the Company is working on the development of a wireless version.

Solzbacher noted that Blackrock is keen to present plans to Neurotech to make the products generally available in 2022.

“We see the beginning of a revolution in the diagnosis and treatment of neurological diseases and disabilities,” said Solzbacher. “Ten years from now, neural implants could be as common as pacemakers are today – offering patients a whole new world of options that restore their independence.”

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