Neurosurgical ablation system receives limited commercial launch
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A Minnesota-based medical technology company announced a limited commercial launch of its OneRF Ablation System, which creates radiofrequency lesions in nervous tissue for functional neurosurgical procedures.
According to a release from NeuroOne Medical Technologies, the system, which received FDA 510(k) clearance in December 2023, is the company’s first device with a therapeutic indication. The thin-film, stereoelectroencephalopathy-guided radio frequency system is capable of both recording electrical activity and ablating nervous tissue while offering temperature control during surgical procedures.
“We are proud to be the first to market with a thin-film electrode technology capable of performing both diagnostic and therapeutic functions utilizing the same electrode,” Dave Rosa said in the release. “We believe physicians and patients will benefit from our technology given it may reduce hospital stays, number of surgeries, and adverse events, while offering significant clinical benefits including temperature control to enhance patient safety.
Rosa further stated that NeuroOne plans to boost recognition and commercialization of the system for other targeted ablation indications by submitting additional 510(k) applications to the FDA.