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FDA Clears Neuropathic Electrode Technology-Med-Tech Innovation

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NeuroOne Medical Technologies is a company focused on improving surgical treatment options and outcomes for patients with neuropathy and is licensed by the US Food and Drug Administration (FDA) 510 (k) for Evo sEEG electrode technology. Is sold temporarily (less than 24 hours). Used in conjunction with recording, monitoring, and stimulators for recording, monitoring, and stimulating electrical signals at the underground level of the brain.

The Evo sEEG electrode is the company’s second FDA 510 (k) -approved product, providing a full line of electrode technology to meet the estimated global market of $ 100 million for patients requiring diagnostic brain mapping procedures. Offers.

In contrast to cortical electrodes, sEEG electrodes provide similar function at the underground level of the brain by using a less invasive process because the upper part of the patient’s skull does not need to be removed. It has become the main technique used in these procedures due to its less invasive placement and underground location.

The company’s Evo Cortical and sEEG electrodes are a portfolio of thin film electrodes. Potential benefits include increased signal clarity and reduced noise. Better tactile feedback during insertion into brain tissue; rapid order processing with automated manufacturing process.

As previously reported, NeuroOne is also advancing a pipeline of therapeutic electrode technologies for brain tissue resection and chronic stimulation use of DBS (Deep Brain Stimulation) and spinal cord stimulation of chronic low back pain. These therapeutic electrode technologies represent a responsive market between $ 500 million and $ 6 billion. ..

NeuroOne CEO Dave Rosa said: An important part of the Evo sEEG electrode commercialization strategy, it is permanently implanted with sEEG ablation electrodes / probes for brain tissue ablation for patients with chronic applications such as epilepsy, Parkinson’s disease, and chronic low back pain. Complete development of stimulating electrodes.

As previously reported, the company expects to be ready for launch by the end of 2021 while waiting for additional regulatory approval for the sEEG label for long-term use.

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2/ https://www.med-technews.com/news/Medtech-Regulatory-News/fda-clears-electrode-technology-for-neurological-disorders/

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