Eden Prairie, Minnesota-based NeuroOne previously announced it resubmitted its 510(k) application for up to 30-day use. The resubmission included additional biocompatibility testing as requested by the FDA.
The new FDA clearance covers temporary use for up to 30 days with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
“I am extremely proud of the entire NeuroOne team and their relentless pursuit of this clearance. Despite the challenges we faced, our team remained focused and persistent in driving this successful conclusion. This is clearly our most exciting and important accomplishment to date. We are now able to advance our commercialization efforts in partnership with Zimmer Biomet, our distribution and development partner. We look forward to continuing to execute our strategic plan, which next up includes our RF ablation system, the Company’s first therapeutic electrode technology,” CEO Dave Rosa said in a news release.
More about NeuroOne’s technology
NeuroOne’s EEG recording technology and brain stimulation and ablation solutions are indicated for use in patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders. The company previously received FDA clearance to market the Evo sEEG electrode technology for temporary use for up to 24 hours.
Zimmer Biomet has an exclusive development and distribution agreement with NeuroOne for its thin film technology. ZB is already selling NeuroOne’s earlier cortical strip and grid electrode devices. The plan has been that if NeuroOne secured the 30-day-use clearance from FDA for the Evo sEEG , ZB would sell it to neurosurgeons for use in its Rosa One Brain robot-assisted neurosurgery system.