Blackrock Neurotech gets FDA breakthrough designation for immobility intervention
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The FDA has granted breakthrough device designation to Blackrock Neurotech for its MoveAgain Brain Computer Interface System, according to a company press release.
The device is expected to allow immobile patients to control a mouse, keyboard, mobile device/tablet, wheelchair or prosthetic device through neuronal activity.
According to the release, more than 5.3 million people in the U.S. have paralysis as a result of central nervous system disorders, autoimmune diseases and spinal cord injuries. The MoveAgain Brain Computer Interface (BCI) System may offer these patients improved mobility and greater independence, such as returning to work, participating in exercise or leisure activities, and communicating more effectively.
“We look forward to working closely with the FDA to prioritize development of the MoveAgain Brain-Computer Interface System, which will bring us closer to our goal of commercialization in 2022,” Marcus Gerhardt, co-founder and CEO of Blackrock Neurotech, said in the release. “Patients with tetraplegia are eager to get access, and we are committed to advancing their ability to increase their independence with our BCI technology.”
The MoveAgain BCI consists of an array implanted in the brain, which decodes intended movement from neuronal activity. Those signals are then transmitted wirelessly to an external device, such as a cursor or wheelchair.
“We are grateful that commercialization of these life-changing products is now possible,” Florian Solzbacher, chairperson and president of Blackrock Neurotech, said in the release. “We are confident we have sufficient safety and efficacy data to support the first applications, and large-scale integration technologies have allowed further miniaturization, which will make a robust wireless version possible. We look forward to submitting plans to make these products widely available in 2022.”
“We are seeing the beginning of a revolution in the diagnosis and treatment of neurological disorders and disabilities,” Solzbacher added. “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.”