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NeuroOne’s CEO Talks About 510(k) Clearance Of Evo sEEG Electrodes

 
• By Hannah Daniel

Medtech Insight spoke to Dave Rosa, CEO of NeuroOne, about working with the FDA to get a 510(k) clearance.

• Source: Shutterstock

NeuroOne’s Evo stereoelectroencephalography (sEEG) electrodes have received 510(k) clearance for less than 30-day use from the US Food and Drug Administration.

The company makes thin-film electrode brain monitors that can be inserted through a tiny hole drilled in the patient’s skull. Evo sEEG electrodes can be used to record monitor, diagnose,...

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