The US Food and Drug Administration (FDA) has granted 510(k) clearance to Neurent Medical’s NEUROMARK system for the treatment of individuals with chronic rhinitis.
Comprising a single-use, handheld bipolar radiofrequency (RF) device and a reusable console with a graphical user interface, the system is designed to conform to the anatomy of the patient and target nerve-rich regions in the nasal cavity.
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Its bioimpedance monitoring technology adjusts energy delivery based on the changes in tissue conductivity.
This method makes sure treatment is precise by continuously evaluating the conditions of the tissue and adjusting energy flow, thereby increasing therapeutic outcomes.
According to the company, the system’s real-time feedback and smart algorithmic control are crucial for directing the proper placement of the electrode and ensuring treatment delivery success.
Its atraumatic leaflets and flexible haft will aid physicians in accessing challenging nasal cavity areas and increase the treatment coverage, along with the posterior areas of the lateral nasal wall.
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By GlobalDataThe system claims to operate by delivering impedance-controlled, low-power RF energy to disrupt parasympathetic nerve signals.
This addresses the primary symptoms of chronic rhinitis, which include rhinorrhoea (runny nose) and persistent congestion in the nasal area.
With the FDA clearance, the system is set for broader availability in the US market. The Ireland-based company focuses on chronic inflammatory sino-nasal disease treatments.
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 [ear, nose, and throat] 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.”
