The FDA approval allows temporary use (less than 30 days) of Evo sEEG Electrode technology with relevant equipment, for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain
NeuroOne Evo sEEG System. (Credit: PRNewswire/NeuroOne Medical Technologies)
US-based medical technology company NeuroOne Medical Technologies has received the US Food and Drug Administration (FDA) 510(k) approval to market its Evo sEEG Electrode technology.
The FDA approval allows temporary use (less than 30 days) of Evo sEEG system for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
In August this year, the company resubmitted its 510(k) application to the FDA for less than 30-day use, which included additional biocompatibility testing as requested by the FDA.
Earlier this month, it received a letter from the FDA, stating that the Evo sEEG System is substantially equivalent to the predicate device and may be marketed in the US.
NeuroOne CEO Dave Rosa said: “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 commercialisation 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.”
NeuroOne said that the Evo sEEG System forms its second FDA-approved product, following Evo Cortical system.
The Evo Cortical and sEEG Electrodes are a portfolio of high-definition thin film electrodes.
Unlike cortical electrodes, sEEG electrodes provide a similar function at the subsurface level of the brain that does not require the removal of a part of the patient’s skull.
The less-invasive placement and subsurface location of sEEG electrodes offer potential advantages including increased signal clarity and reduced noise.
In addition, the electrodes offer better tactile feedback during insertion into brain tissue, and faster order fulfilment due to an automated manufacturing process, said the company.
NeuroOne is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders.
The company is advancing a pipeline of therapeutic electrode technologies for brain tissue ablation and chronic stimulation use for deep brain stimulation (DBS) and spinal cord stimulation for chronic back pain.