NeuroOne Tried Again – And Succeeded

Persistence has paid off for NeuroOne Medical Technologies, a company that develops electrode technology for diagnostic brain mapping procedures.

NeuroOne's Evo sEEG system had previously been FDA cleared for less than 24 hours use, but earlier this year FDA shot down the company's bid to extend its use. Instead of giving up, the company resubmitted its 510(k) application for less than 30-day use, along with additional biocompatibility testing, and the application was successful.