FDA designates brain-computer interface as Breakthrough Device

September 09, 2020 //By Rich Pell
Brain-computer interface receives FDA 'breakthrough' designation
Neurovascular bioelectronics medicine company Synchron has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its fully-implantable medical device that can translate brain activity or stimulate the nervous system from the inside of a blood vessel, without the need for open brain surgery.

The device, called the Stentrode, has already been implanted in patients with upper-limb paralysis and is currently being evaluated for its ability to enable patients with paralysis to regain functional independence by control of digital devices through thought alone. The FDA's Breakthrough Devices Program is designed to expedite the development and FDA review of innovative solutions for more effective treatment of irreversibly debilitating diseases or conditions, among other purposes, and will lower the burden required for Medicare reimbursement.

"As this is a first-of-its-kind device," says Thomas Oxley, MD, PhD, CEO of Synchron, "we look forward to working closely with the FDA to prioritize development of the Stentrode and ensure access for patients with paralysis, as well as lay the groundwork for future indications for brain-computer interfaces."

Designed so that patients can train their brains to wirelessly control external systems without the need for using their hands or voice, the Stentrode, says the company, is the only investigational, implantable device, that does not require open brain surgery. This compares to other neural interface devices - such as those being developed by Elon Musk's Neuralink and BrainGate - which currently require drilling into the skull, and direct puncture into the brain, to achieve device implantation.

Similar to the procedure used for implantation of cardiac pacemakers, implantation of the Stentrode is minimally invasive during which the device is delivered to the brain through blood vessels. As the Stentrode system is small and flexible enough to safely pass through curving blood vessels, insertion of the device does not require open brain surgery, which may reduce risk of brain tissue rejection of the device, which has been a significant problem for other techniques.

The technology, says the company, relies on a revolutionary brain-controlled hands-free app platform called brainOS to translate the brain activity into a standardized digital language, directly through thought, to control apps that restore communication and limb function. In addition, brainPort, a


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