With this clearance, the device may now be utilized during procedures of the skin, subcutaneous tissues and nasal passages, for applications in podiatry, dermatology, plastic surgery, and otolaryngology. Advancements in the ease and simple operation of the Noveon system may enhance professional office workflow while eliminating the requirement for a physician to operate the device in most states, the company has said.
The Noveon is a light-based system that photo-biologically targets the elimination of bacterial and fungal infections through a unique, near-infrared, photo-inactivation effect, while preserving healthy tissue and promoting recovery.
Nomir has completed two IRB human studies with Noveon against methicillin-resistant Staphylococcus aureus (MRSA) carriage and infection in the nares (nose). Based on positive data from these studies, Nomir is initiating a pilot study with Noveon for the reduction of bioburden in diabetic foot ulcers.
Richard Burtt, president and CEO of Nomir Medical Technologies, said: The granting of this 510(k) approval is another significant milestone in Nomir’s regulatory process, which we have been pursuing rigorously, and paves the way for future 510(k) multi-site, disease-specific applications.
This new FDA clearance highlights the continued success of the Nomir team and its implementation of our regulatory plans for commercialization of our unique photo-biological, anti-infective Noveon system.