Neurent Medical Announces 510(k) Clearance of its Next Generation NEUROMARK® System
Galway, Ireland – June 11, 2025 — Neurent Medical, a leader in pioneering non-surgical solutions for chronic sino-nasal inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Next Generation NEUROMARK® System, marking a major milestone in advancing care for patients suffering from Chronic Rhinitis. This latest advancement in the NEUROMARK platform delivers a new level of control, confirmation, and confidence for otolaryngologists.
The new system is designed to optimize the treatment of posterior nasal nerves by providing real-time feedback, guiding proper electrode placement, and confirming successful treatment delivery. The flexible shaft and atraumatic leaflets conform to patient anatomy, enabling physicians to reach challenging areas in the nasal cavity while maximizing treatment coverage. The NEUROMARK System delivers impedance-controlled, low-power radiofrequency (RF) energy to disrupt the parasympathetic nerve signals, addressing key symptoms of Chronic Rhinitis such as persistent nasal congestion and rhinorrhea (runny nose).