FDA OKs RF Medical’s MYGEN M-3004 and MYOBLATE RF Ablation System

Korean thermal ablation system manufacturer RF Medical Co. has gained U.S. Food and Drug Administration (FDA) clearance for its MYGEN M-3004 generator and specialized electrodes, including MYOBLATE.
 
Both products are now commercially available in the U.S.
 
MYGEN M-3004 enables a combination of monopolar and bipolar modes. It delivers radiofrequency (RF) energy more efficiently, according to the company, and supports optimized algorithm modes to use for a variety of lesions depending on shape and size.
 
MYOBLATE brings another option to women suffering from uterine fibroids as a less invasive, more patient-friendly alternative to hysteroscopy or myomectomy. The electrodes are meant for soft tissue coagulation and ablation utilizing radiofrequency ablation (RFA). RFA is a heat-treatment approach to safely treat fibroids individually, while keeping the uterus intact.
 
“The world’s medical device market is showing remarkable growth driven by cutting-edge minimally invasive technology and its industrial value is limitless. RF Medical is working diligently in an effort to keep pace with the advanced medical market. Improving the health and safety of mankind is our top priority and we are dedicated to carrying our mission as a leading medical device company through continuous investments in superior workforce and R&D,” Mike Jun, CEO of RF Medical told the press.