FDA Grants Breakthrough Device Designation for Brain Implant Technology

ByLance T. Lee

Oct 19, 2022


October 19, 2022

1 minute read

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The FDA has granted Breakthrough Device Designation to neurotechnology company Axoft for its brain-machine interface for treating long-term neurological disorders.

According to a release from Axoft, the minimally invasive implants mimic the mechanical and structural properties of the brain and are gliosis-free, meaning they can safely reside in the central nervous system long-term. The electrical stability of the interface for tracking brain signals over an extended period allows it to provide an ultra-high density of sensors to maximize information exchange between the brain and electronics.

Neurotechnology company Axoft plans to launch a new brain-machine interface to treat long-term neurological disorders such as epilepsy, cerebral palsy. Source: Adobe Stock.

“The pursuit of a high quality of life, compounded by the growing financial burden of neurological disorders due to an aging population, is driving the demand for less invasive and more powerful neurological tools,” Paul Le Floch, The co-founder and CEO of Axoft, said in the statement.

To avoid the risk of scarring and infection sometimes seen with rigid implants, Axoft’s brain-machine interface uses bioinspired material to fabricate high-density probes with long-term stability and biocompatibility in the brain, the company said. Additionally, the implant material remains functional as the brain moves or grows, minimizing the need for replacement and providing a long-term solution to seamlessly connect the brain to electronics.

The implants can embed up to 1,024 electrodes in a single strand thinner than a credit card, the statement said.

According to the release, the company plans to introduce the new technology in a phased approach, first addressing diseases that have large patient populations underserved by current medical technology, as well as diseases such as cerebral palsy. pediatrics and epilepsy where patients undergo treatment for permanent conditions. .

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