FDA grants breakthrough device designation for brain implant technology

The FDA has granted breakthrough device designation to neurotechnology company Axoft for its brain-machine interface to treat long-term neurological disorders.

According to an Axoft release, the minimally invasive implants mimic the mechanical and structural properties of the brain and are gliosis-free, meaning they can reside in the central nervous system long term without harm. The interface’s electrical stability to track brain signals over an extended period allows it to deliver an ultra-high density of sensors to maximize information exchange between the brain and electronics.

“The pursuit of elevated quality of life, compounded by the increasing financial burden of neurological disorders due to an aging population, are driving the demand for less invasive, more powerful neurological tools,” Paul Le Floch, Axoft co-founder and CEO, stated in the release.

To avoid the risk for scarring and infection sometimes seen with rigid implants, Axoft’s brain-machine interface uses bioinspired material to make high density probes with long-term stability and biocompatibility in the brain, the company said. Further, the implant material stays functional as the brain shifts or grows, minimizing the need for replacement and offering 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 release stated.

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