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The BCI System MoveAgain Wins FDA Breakthrough Device Status
Brain-computer Interface enables patients to control devices with thoughts.
Posted November 19, 2021 Reviewed by Kaja Perina
Brain-computer interfaces (BCIs), also known as brain-machine interfaces (BMIs) are life-transforming devices that convert brain thoughts into commands to operate external devices for those who have impaired or lost movement or speech. In a historic milestone for the brain-computer interface industry, Blackrock Neurotech’s MoveAgain BCI System was granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) earlier this week.
The demand for BCIs is growing globally and expected to reach USD 3.7 billion in revenues with an annual compound growth rate of 15.5 percent during 2020-2027 according to estimates from Grand View Research. BCI companies include Bryan Johnson’s Kernel, Thomas Oxley’s Synchron, Inc., Elon Musk’s Neuralink, along with Medtronic Inc. (NYSE: MDT), Boston Scientific Corporation (NYSE: BSX), Abbott Laboratories (NYSE:ABT), and others. Even auto makers are entering the market as Mercedes-Benz AG announced plans to integrate a brain-computer interface in its future VISION AVTR concept vehicle using NextMind’s non-invasive EEG (electroencephalogram) technology and artificial intelligence (AI) to read and decode electrical signals from the brain to identify the user’s visual focus.
Blackrock Neurotech provides neurotech devices and brain-computer interfaces solutions to enable patients to walk, communicate, see, hear, and feel again. Founded in 2008 by Florian Solzbacher and Marcus Gerhardt, investors in Blackrock Neurotech (formerly Blackrock Microsystems) include Pieter Thiel, Time Sievers, re.Mind Capital, and Sorenson Impact according to Crunchbase. According to the company, 29 out of the 31 people globally with an implanted brain-computer interface are using neurotechnology from Blackrock.
The FDA Breakthrough Devices Program is a voluntary program that gives manufacturers the ability to engage with FDA experts during the premarket review phase and gives prioritized review of submissions. It is intended to enable patients to have more timely access to these medical devices and device-led combination products that diagnose or treat life-threatening or irreversibly debilitating diseases and conditions by expediting the development, assessment, and review process.
The MoveAgain system is designed to enable immobile patients to use their brain signals from thinking to control external devices such as a wheelchair, prosthetics, mobile phones, computer cursor, or keyboard.
"We are seeing the beginning of a revolution in the diagnosis and treatment of neurological disorders and disabilities," said Florian Solzbacher, Chairman and President of Blackrock Neurotech in a statement earlier this week. "Ten years from now, neural implants could be as common as cardiac pacemakers are today -- offering patients a whole new world of options that restore their independence."
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