NeuroOne sEEG Electrode Approved for 30-Day Use
NeuroOne Medical Technologies has received 510(k) clearance from the FDA to market its Evo sEEG electrode technology for less than 30-day use to record, monitor and stimulate electrical signals at the subsurface level of the brain.
The device is less invasive than alternatives because it does not require removal of the top portion of the patient's skull to detect unusual brain activity in patients with stroke, head trauma, recent seizures and other critical conditions.
The agency initially declined to approve the 30-day use. But the company resubmitted its 510(k) application in August with additional biocompatibility data requested by the FDA.
The agency previously said the device was not substantially equivalent to the reference product in the extended use from less than 24 hours to less than 30 days, but permitted the submission of a special 510(k) application with more information relating to subacute toxicity.