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  3. Neurent Medical Receives Us Fdas 510k Clearance For Neuromark System
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  • 16 Jun 2025
  • Admin
  • News Article

Neurent Medical receives US FDA’s 510(k) clearance for Neuromark system

Overview

Galway-headquartered Neurent Medical, a leader in pioneering non-surgical solutions for chronic sinonasal inflammatory diseases, announced that the US 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. 

Present advancements

• This latest advancement in the Neuromark platform delivers a new level of control, confirmation, and confidence for otolaryngologists.  

• This highlights our continued commitment to innovations that empower ENTs to treat patients with greater confidence.  

• 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).

Successful collab result

Developed in collaboration with leading ENT experts, the enhanced Neuromark system reflects meaningful innovation and delivers real-time feedback to improve patient care.

Words from the CEO: Neurent Medical

• "We have just completed a highly successful commercial validation phase, positioning the Neuromark system at the forefront of chronic rhinitis care,"" said Brian Shields, CEO of Neurent Medical. 

• "During this phase, we have 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 empowers ENTs to treat patients with greater confidence.""

Statement from the CMO: ENT Specialty Partners

• "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."" said Dr. Marc Dubin, chief medical officer, ENT Specialty Partners. 

• "The latest generation of the Neuromark System reflects this commitment, incorporating usability enhancements and real- time feedback capabilities to support precise treatment delivery.""
Impact of this clearance
This US FDA clearance paves the way for broader US availability of the Neuromark system as Neurent Medical continues its mission to redefine the standard of care for chronic rhinitis, affecting nearly 1 in 4 Americans.

About the company: Neurent Medical

• Neurent Medical is pioneering innovative treatments for chronic inflammatory sinonasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. 

• Its proprietary Neuromark technology, with a unique design and advanced smart algorithmic control, allows physicians to precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate chronic rhinitis symptoms and improve patient quality of life.

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