The Wyss Center announces CE mark for its brain-computer interface software for communication, NeuroKey BCI

NeuroKey BCI enables people who are completely locked-in to communicate in real time

Geneva, Switzerland, 28 May 2021 - The Wyss Center announced today the CE (Conformité Européenne) mark Class I medical device for its NeuroKey BCI. It is the first clinical application of the Center’s NeuroKey neural signal processing platform to be launched in the European Union (EU) and can work directly with implantable devices that acquire high channel count, high frequency brain signals.

“We developed NeuroKey because we couldn’t find a software platform that met our needs,” says David Ibáñez Soria, PhD, Wyss Center Brain Machine Interface Scientist and Program Manager for NeuroKey. “We needed software that could handle large data streams in real time from hundreds of channels recording from the human brain. We also needed the flexibility to record from various types of electrodes. With our first application now CE marked, we look forward to bringing our solution to more clinical settings.”

NeuroKey BCI is currently in home-use as part of a single case study to enable communication for a user who is completely locked-in because of ALS (amyotrophic lateral sclerosis). The software decodes intention from neural signals acquired from implanted electrodes in real-time and runs an auditory feedback speller that prompts the user to select letters to form words and sentences. NeuroKey BCI also provides a Yes/No question option using auditory feedback to enable quick responses to closed questions.

Enabling home-use of brain computer interfaces (BCIs) has been a priority for the team throughout the development of NeuroKey. The simple user-friendly graphical interface makes it easy for family or caregivers to launch and calibrate the BCI system. At the same time, important data is collected to allow Wyss Center scientists to improve their algorithms for future versions.

“We believe that that user-friendly medical-grade neural processing software will help drive adoption of BCI technologies by clinicians and ultimately improve the lives of people who benefit from BCIs for movement and communication,” says George Kouvas, MBA, Wyss Center Chief Technology Officer.

The team is integrating NeuroKey with ABILITY, a fully implantable brain-computer interface under development at the Center, to bring cutting-edge technology for the restoration of movement and communication, closer to long-term daily use at home. Further development of the NeuroKey platform is enabling its integration with other monitoring devices to simultaneously process additional physiological data such as temperature and blood flow.

NeuroKey BCI for communication is medical device software of safety class A as per IEC 62304 and CE-marked as Class I as per the Medical Device Directive 93/42/EEC. CE marking indicates that a product has been assessed and deemed to meet European Union safety, health and environmental protection requirements.