Sam Brusco, Associate Editor03.26.24
NeuroOne began limited commercial launch of its OneRF ablation system.
The OneRF ablation system has U.S. Food and Drug Administration (FDA) 510(k) clearance to create radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. It achieved this FDA nod in December 2023.
The system is NeuroOne’s first device with a therapeutic indication and its third FDA-cleared device. The company now has a full line of electrode tech for diagnostic brain mapping procedures and RF ablation using the same sEEG electrode.
NeuroOne’s other FDA-cleared devices include the Evo cortical and sEEG electrode product lines used mainly for recording electrical activity in the brain for under 30 days.
“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.
Rosa said the company expects to begin shipping systems this week to centers participating in its limited launch, with cases slated to begin 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,” Rosa said. “Looking ahead, we plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications.”
The OneRF ablation system has U.S. Food and Drug Administration (FDA) 510(k) clearance to create radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. It achieved this FDA nod in December 2023.
The system is NeuroOne’s first device with a therapeutic indication and its third FDA-cleared device. The company now has a full line of electrode tech for diagnostic brain mapping procedures and RF ablation using the same sEEG electrode.
NeuroOne’s other FDA-cleared devices include the Evo cortical and sEEG electrode product lines used mainly for recording electrical activity in the brain for under 30 days.
“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.
Rosa said the company expects to begin shipping systems this week to centers participating in its limited launch, with cases slated to begin 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,” Rosa said. “Looking ahead, we plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications.”