NeuroOne Medical Technologies has announced the limited commercial launch of its OneRF Ablation System, a thin-film, stereoelectroencephalography (sEEG)-guided radiofrequency (RF) system.

The system received 510(k) clearance from the US Food and Drug Administration (FDA) in December 2023 for the creation of RF lesions in nervous tissue for functional neurosurgical procedures.

The OneRF Ablation System is designed for both recording electrical activity and ablating nervous tissue and features temperature controls.

NeuroOne CEO Dave Rosa said: “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.

“We expect to start shipping systems this week to centres participating in our limited launch with cases already scheduled starting in April.”

Representing NeuroOne’s first therapeutic device and its third FDA-cleared product, the system complements NeuroOne’s existing portfolio that includes the Evo cortical and sEEG electrodes, mainly used to record electrical activity in the brain for less than 30 days.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Rosa added: “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 company anticipates the current global market for brain ablation to be at least $100m and expects significant growth.