Neurent Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation Neuromark system to treat chronic rhinitis.
The Neuromark system is designed to enhance the control and precision available to otolaryngologists.
By offering real-time feedback, it aids in the accurate placement of electrodes and confirms effective treatment delivery.
The system’s flexible shaft and atraumatic leaflets adapt to patient anatomy, allowing physicians to access difficult areas within the nasal cavity, thereby improving treatment coverage.
The Neuromark system employs impedance-controlled, low-power radiofrequency energy to disrupt parasympathetic nerve signals. This approach targets symptoms of chronic rhinitis, such as continuous nasal congestion and rhinorrhoea.
Neurent Medical CEO Brian Shields said: “We have just completed a highly successful commercial validation phase, positioning the Neuromark system at the forefront of chronic rhinitis care.
“During this phase, we collaborated with leading General ENT and Rhinology specialists across both private practice and academic settings. Their insights were instrumental in shaping this next-generation system.
“I am incredibly proud of how their feedback translated into meaningful technological improvements. This milestone highlights our continued commitment to innovations that empower ENTs to treat patients with greater confidence.”
With FDA clearance, Neurent Medical can expand the availability of its Neuromark system across the US.
ENT Specialty Partners chief medical officer Dr Marc Dubin said: “I have worked closely with the Neurent Medical team from the beginning and continue to be impressed by their dedication to ENT surgeons and our patients.
“The latest generation of the Neuromark system reflects this commitment, incorporating usability enhancements and real-time feedback capabilities to support precise treatment delivery.”
