FDA Refuses Second Clearance to NeuroOne’s Evo sEEG Electrode

The FDA has declined to issue a 510(k) clearance to NeuroOne Medical Technologies’ Evo sEEG electrode for extended intraoperative use, and has called for new data relating to the subacute toxicity endpoint, the Eden Prairie, Minn.-based company said.

The device was previously cleared for temporary use for less than 24 hours.

The agency sent the company a letter May 13 letter stating that it was upholding its decision that the device is not substantially equivalent for extended use and that it needed to see new data relating to the subacute toxicity endpoint.  The FDA said that the company may submit a new 510(k) with more data on subacute toxicity.

The company said it is collecting the data and intends to submit a special 510(k) application in August.