FDA asked to approve OneRF ablation system for Parkinson’s

NeuroOne Medical Technologies is seeking approval from the U.S. Food and Drug Administration (FDA) for its OneRF ablation system, which aims to remove select regions of brain tissue as a way of treating neurological conditions like Parkinson’s disease. The company submitted its request in the form of…

NeuroOne Evo sEEG electrode device available commercially in US

NeuroOne Medical Technologies‘ Evo stereoelectroencephalography (sEEG) electrodes for measuring or stimulating brain activity in people with neurological diseases like Parkinson’s disease or epilepsy are now available commercially in the U.S. The electrodes were approved by the U.S. Food and Drug Administration (FDA) in October for less than…

FDA Clears NeuroOne Evo sEEG Device for Use Up to 30 Days

The U.S. Food and Drug Administration (FDA) has granted NeuroOne Medical Technologies clearance to market its Evo stereoelectroencephalography (sEEG) electrode technology for temporary use of less than 30 days. The device — previously cleared by the FDA for use of less than one day — is used to measure…

FDA Seeks More Data Before OK’ing Extended Use Of Brain Electrodes

The U.S. Food and Drug Administration (FDA) has upheld its decision that the Evo stereoelectroencephalography (sEEG) electrode, designed to monitor brain activity in people with Parkinson’s disease and other neurological conditions in a minimally invasive way, cannot be marketed for long-term use until more safety data is provided. Last…