Axoft’s BMI Device Gains Breakthrough Device Status
The FDA has granted Axoft a Breakthrough Device designation for its brain-machine interface (BMI) device for use in treatment of long-term neurological disorders.
The device features ultra-flexible nanoelectronics that mimic the mechanical and structural properties of the brain. The implant is made of a malleable material that can continue to function as the brain shifts or grows, minimizing the need for replacement, the company said.
Axoft’s implants can embed up to 1,024 electrodes in a single strand thinner than a credit card, enabling more complex signaling than the currently approved BMI systems that are limited to just 96 electrodes.
The FDA grants the Breakthrough Device designation to help speed up reviews of medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.