NeuroOne Medical initiates limited commercial launch of OneRF

NeuroOne Medical Technologies Corporation announced that it has initiated a limited commercial launch of its OneRF Ablation System, which has FDA 510(k) clearance for creation of radiofrequency 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 utilizing the same electrode,” said Dave Rosa, CEO of NeuroOne. “We expect to start shipping systems this week to centers 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.”