Neurent Medical, a leader in non-surgical treatments for chronic sinonasal inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation NEUROMARK® System. This milestone marks a significant advancement in the treatment of Chronic Rhinitis and reinforces the company’s commitment to empowering ENT specialists with precise, minimally invasive solutions.
The updated NEUROMARK System introduces enhanced control, confirmation, and confidence for otolaryngologists managing Chronic Rhinitis—a condition affecting nearly one in four Americans. The system is designed to optimize treatment by targeting the posterior nasal nerves using real-time feedback mechanisms. These features assist in guiding electrode placement, ensuring accurate positioning, and confirming successful therapy delivery.
The device features a flexible shaft and atraumatic leaflets that conform to a patient’s unique nasal anatomy, enabling access to challenging treatment areas and maximizing coverage. By delivering low-power, impedance-controlled radiofrequency (RF) energy, the system effectively disrupts parasympathetic nerve signals that contribute to chronic nasal congestion and rhinorrhea (runny nose).
“We have just concluded a highly successful commercial validation phase, working closely with leading ENT and rhinology experts across both private and academic settings,” said Brian Shields, CEO of Neurent Medical. “Their feedback played a critical role in shaping the enhancements in this next-generation system. This FDA clearance is a testament to our ongoing commitment to innovation and to helping ENT specialists treat patients with greater confidence.”
Dr. Marc Dubin, Chief Medical Officer at ENT Specialty Partners, echoed this sentiment: “Having worked with the Neurent team since the beginning, I’ve witnessed their dedication to advancing care for both ENT surgeons and patients. The new NEUROMARK System integrates valuable usability improvements and real-time treatment confirmation, making it a powerful tool in Chronic Rhinitis management.”
With FDA clearance secured, Neurent Medical is now set to expand the availability of the NEUROMARK System across the U.S., supporting its mission to redefine the standard of care for millions of Americans suffering from Chronic Rhinitis.