FDA grants 510(k) clearance for temperature-controlled neurosurgical ablation system

The FDA has granted 510(k) clearance for marketing of an ablation system that creates radiofrequency lesions in nervous tissue for functional neurosurgical procedures, according to the manufacturer.

According to a release from NeuroOne Medical Technologies Corp., the OneRF Ablation System is the company’s first device with a therapeutic indication and third to gain 510(k) clearance.

NeuroOne additionally revealed in the release that OneRF is the first FDA-cleared thin-film, sEEG-guided radiofrequency system capable of both recording electrical activity along with the ability to ablate nervous tissue while maintaining temperature control during surgery.

“When NeuroOne was founded, one of our goals was to be the first to develop and commercialize thin-film electrodes capable of performing both diagnostic and therapeutic functions and offer a better methodology to treat patients suffering from a variety of neurological conditions,” NeuroOne CEO Dave Rosa said in the release. “We believe we have the potential to change the way these surgeries are performed so that patients may only need to go through surgery once for both diagnostic and therapeutic procedures.”

NeuroOne expects to commercially launch the system either directly or through a partnership during the first half of 2024, according to the release.