Cognixion wins FDA breakthrough designation for BCI tech

May 4, 2023 By Sean Whooley

Santa Barbara, California-based Cognixion designed the Cognixion One Axon as an assisted reality device. It utilizes bionic combination or AI, augmented reality and assistive technology.

The company designed the system to help people with severe motor impairments communicate and interact more effectively and independently. It utilizes electroencephalogram (EEG) technology to provide a BCI. This enables patients with advanced disease progression to communicate responses in a wearable, augmented reality headset.

By integrating AI, Cognixion aims for the device to rapidly support communication intentions and desired outcomes. It could provide suggestions capable of quick selection and audible and visual communication. The company specifically designed the device to help individuals with neurodegenerative conditions. Those include Amyotrophic Lateral Sclerosis, also known as ALS or Lou Gehrig's disease and MND (Motor Neuron Disease). It could also extend to conditions like traumatic injuries and cerebral palsy.

Cognixion says that, at present, no device exists that enables fully paralyzed or locked-in patients to communicate once the current standard of care, eye-tracking, is no longer usable for their disease state due to ocular motor decline.

"This FDA breakthrough device designation is a significant milestone, and we are thrilled to receive it for our Cognixion ONE device," said Andreas Forsland, CEO and founder of Cognixion. "It validates the potential of our technology to make a real difference in the lives of individuals with severe motor impairments and underscores the importance of how AI can be used to assist people in everyday situations. We are excited to continue our work to bring this life-changing technology to those who need it most."

Cognixion believes its device could be prescribed and utilized without surgical procedures or the need for significant training. This could offer a new wrinkle in the burgeoning BCI space.

Blackrock Neurotech has been leading the way in the BCI space for multiple decades. The company develops the NeuroPort Array neural interfacing system. It's been used in human BCIs since 2004. The system helps patients regain tactile function, movement of limbs and prosthetics and the ability to control digital devices. Blackrock also has a next-gen BCI, unveiled in November 2022, called Neuralace. The system looks like a piece of lace and is thinner than an eyelash.

Synchron, meanwhile, has the backing of the likes of investors such as Bill Gates and Jeff Bezos. Its stent-like Stentrode utilizes a minimally invasive endovascular procedure. Clinical study results for Stentrode demonstrated long-term safety for four people with severe bilateral upper-limb paralysis.

The Elon Musk-led company, Neuralink, has ground to make up against the stiff competition in the BCI space. Neuralink designed its N1 implant to recharge remotely and work with electrode-laced threads that go further into the brain. The company developed its R1 robot to implant the BCI system into the brain while avoiding vasculature.

During a Nov. 30, 2022 show and tell, Musk said that Neuralink would have the first in-human implant of its N1 device within the next six months. Reuters reported in March that Neuralink sought FDA permission in early 2022 for human clinical trials of its BCI. However, those reports said the company received an application rejection from the agency. To add to Neuralink's troubles, the company may face a U.S. Department of Agriculture Inspector General animal welfare investigation.

Filed Under: Digital Health, Food & Drug Administration (FDA), Health Technology, Neurological, Regulatory/Compliance, Software / IT Tagged With: brain-computer interface, Cognixion, FDA