FDA clears NeuroOne's Evo sEEG electrode for 30-day use - Mass Device

The Evo sEEG uses NeuroOne’s hi-definition thin-film electrodes technology. [Photo courtesy of NeuroOne]

NeuroOne contiguous announced it received expanded FDA 510(k) clearance to marketplace its Evo sEEG Electrode exertion for impermanent usage with encephalon recording, monitoring and stimulation equipment.

Eden Prairie, Minnesota-based NeuroOne antecedently announced it resubmitted its 510(k) application for up to 30-day use. The resubmission included further biocompatibility investigating arsenic requested by the FDA.

The caller FDA clearance covers impermanent usage for up to 30 days with recording, monitoring and stimulation instrumentality for the recording, monitoring and stimulation of electrical signals astatine the subsurface level of the brain.

“I americium highly arrogant of the full NeuroOne squad and their relentless pursuit of this clearance. Despite the challenges we faced, our squad remained focused and persistent successful driving this palmy conclusion. This is intelligibly our astir breathtaking and important accomplishment to date. We are present capable to beforehand our commercialization efforts in concern with Zimmer Biomet, our organisation and improvement partner. We look guardant to continuing to execute our strategical plan, which adjacent up includes our RF ablation system, the Company’s archetypal therapeutic electrode technology,” CEO Dave Rosa said successful a news release.

More astir NeuroOne’s technology

NeuroOne’s EEG signaling exertion and encephalon stimulation and ablation solutions are indicated for usage successful patients with epilepsy, Parkinson’s disease, dystonia, indispensable tremors, chronic symptom owed to failed backmost surgeries and different related neurological disorders. The institution antecedently received FDA clearance to marketplace the Evo sEEG electrode exertion for impermanent usage for up to 24 hours.

Zimmer Biomet has an exclusive improvement and organisation statement with NeuroOne for its bladed movie technology. ZB is already selling NeuroOne’s earlier cortical portion and grid electrode devices. The program has been that if NeuroOne secured the 30-day-use clearance from FDA for the Evo sEEG , ZB would merchantability it to neurosurgeons for usage successful its Rosa One Brain robot-assisted neurosurgery system.