NeuroOne Medical Technologies has announced that it has initiated a limited commercial launch of its OneRF ablation system, which has US Food and Drug Administration (FDA) 510(k) clearance for creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures.
“Today is an exciting day for NeuroOne as we begin the limited commercial launch of our OneRF ablation system. We are proud to be the first to market with a thin-film electrode technology capable of performing both diagnostic and therapeutic functions utilising the same electrode,” said Dave Rosa, the company’s chief executive officer. “We expect to start shipping systems this week to centres participating in our limited launch, with cases already scheduled starting in April.
“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. Looking ahead, we plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications.”
The OneRF ablation system is NeuroOne’s first device with a therapeutic indication and its third FDA 510(k)-cleared device—joining the Evo cortical and stereoelectroencephalography (sEEG) electrode product lines, which are used primarily for recording electrical activity in the brain for less than 30 days.
In a recent press release, NeuroOne notes that this limited commercial launch of the OneRF ablation system has been initiated “earlier than expected”.
