FDA Rejects Additional Clearance for NeuroOne Medical Technologies’ Electrodes

NeuroOne Medical Technologies said the FDA denied its application for an additional 510(k) clearance for its Evo stereo electroencephalography (sEEG) electrodes.

The FDA previously granted 510(k) clearance to the device last September, for temporary use (less than 24 hours) in recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Two months later, the company submitted a request to the FDA seeking an additional 510(k) clearance for use of its Evo sEEG electrode technology for less than 30 days.

The FDA told the company that it was rejecting the application, “based on a finding of non-substantial equivalence,” to the approved reference product.  The agency added that NeuroOne may re-submit a new 510(k) application if it has biocompatibility data it believes can show its device to be substantially equivalent.