Somnus submits 510(k) for Somnoplasty RF ablation system for habitual snoring.
This article was originally published in The Gray Sheet
Executive Summary
SOMNUS 510(k) FOR SOMNOPLASTY ABLATION SYSTEM TO TREAT HABITUAL SNORING was submitted to FDA the week of April 14, the company says. The submission includes data from a 40-patient study conducted at the Stanford University Medical Center that evaluates use of Somnus Medical Technologies' Somnoplasty system for reducing snoring.