FDA hands Breakthrough clearance for neural implant for immobile patients – Med-Tech Innovation – DLIT

The US Food and Drug Administration (FDA) has granted Breakthrough Device designation for Blackrock Neurotech’s MoveAgain Brain Computer Interface (BCI) System.

The system has been developed to provide immobile patients the ability to control a mouse cursor, keyboard, mobile device/tablet, wheelchair, or prosthetic device by thinking.

The FDA Breakthrough Device designation is there to expedite the review of innovative technologies that can improve the lives of people with irreversibly debilitating diseases or conditions.

It’s thought that 5.35 million people in the United States live with some form of paralysis because of central nervous system disorders, autoimmune diseases, and spinal cord injuries (SCIs). Many of these patients are completely dependent on permanent support from a caretaker, and their ability to communicate or control their external environment is severely limited. 

Blackrock’s portable MoveAgain BCI could offer these patients new possibilities for improved mobility and independence – such as returning to work, participating in leisure activities, and communicating more effectively and quickly. The goal of the device is to achieve long-term improvement in movement and independence, reduce patient reliance on caregivers and help them better engage with society and the world. 

Marcus Gerhardt, co-founder and CEO of Blackrock Neurotech, said: “We look forward to working closely with the FDA to prioritise development of the MoveAgain Brain-Computer Interface System, which will bring us closer to our goal of commercialisation in 2022. 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 system 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, providing people with control of their external environment.

Florian Solzbacher, chairman and president of Blackrock Neurotech, said: “We are very grateful that commercialisation of these life-changing products is now possible. We are confident we have sufficient safety and efficacy data to support the first applications, and very large-scale integration technologies have allowed further miniaturisation, which will make a robust wireless version possible. We look forward to submitting plans to make these products widely available in 2022.”

Devices qualifying for the Breakthrough Device designation must represent a novel application of an existing technology and show that it has the potential to provide for more effective treatment of irreversibly debilitating diseases or conditions.

Solzbacher added: “We are seeing the beginning of a revolution in the diagnosis and treatment of neurological disorders and disabilities. 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.”