Fierce Biotech December 11, 2023
About two years after landing the initial FDA clearance for its stereoelectroencephalography electrode—which can be used to record, monitor and stimulate brain signals for up to 30 days under a since-expanded indication—NeuroOne has now earned another agency nod that builds on the sEEG electrode’s capabilities.
While both the sEEG device and the Evo cortical electrode, which earned NeuroOne’s first-ever FDA clearance back in 2019, are designed to be used as diagnostic tools for neurological conditions like epilepsy and Parkinson’s disease, the newly cleared OneRF system is the company’s first to tack on a therapeutic indication as well, according to a Monday announcement.
The OneRF system conducts both monitoring and treatment through a single sEEG electrode that has been surgically placed...
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