Milan, Italy-based Wise designed the single-use medical device for use on the brain surface in IONM.
According to a news release, it marks the first product to receive FDA clearance within the WiseNeuro monitoring product family. It already holds CE mark approval, having garnered that in May 2021.
Wise validated the WCS in a multi-clinic, pre-market clinical study in Europe. The study demonstrated the safety, performance and usability of the product. It also demonstrated stronger performance in terms of electrical impedance in physiological conditions compared to conventional cortical electrodes available on the market.
The company said it also showed better adhesion, conformability and stability on the brain surface.
WCS works intraoperatively with recording, monitoring and st…