FDA clears RF Medical's MYGEN™ M-3004 and MYOBLATE™ Radiofrequency Ablation System
Tuesday, December 13, 2022
RF Medical Co., Ltd. is a premier Korean-based medical company serving the healthcare industry for almost two decades. Recently, FDA cleared RF Medical's patented MYGEN™ M-3004 generator and MYOBLATE™ radiofrequency ablation system.
Radiofrequency ablation is evolving at a rapid pace. Commonly used to treat damaged tissue and tumors, the technology enabling fulguration or radiofrequency ablation is in high demand among surgeons and medical practices worldwide.
RF Medical Co., Ltd. is a leading Korean thermal ablation system manufacturer and the creator of the critically acclaimed MYGEN™ M-3004 generator and specialized electrodes including MYOBLATE™. Both of these products have been cleared by FDA and are now commercially available in the United States.
RF Medical's chief executive officer Mike Jun imparted that the company is delighted to extend some of its finest medical equipment to the American market. Mr. Jun is confident that MYGEN™ and MYOBLATE™ will empower US-based medical facilities and practices, and will modernize the standard of care for minimally-invasive practices in the United States.
According to Mr. Mike Jun, RF Medical's commitment to developing effective, affordable, and minimally invasive medical devices is embodied in its latest inventions, communicating the following:
"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," said Mike Jun, the CEO of RF Medical.
The MYGEN™ M-3004 is a medical device that enables a combination of monopolar and bipolar modes. In addition to delivering radiofrequency energy more effectively, it also supports optimized algorithm modes for use in a variety of lesions depending on their size and shape.
The clearance of the MYOBLATE™ System is expected to bring another option to women suffering from uterine fibroids. A recent study showed that approximately 70-80% of women will experience this condition at some point; the MYOBLATE™ system will then be a less-invasive, and more patient friendly alternative to hysteroscopy or myomectomy.
MYOBLATE™ electrodes are intended for soft tissue coagulation and ablation to treat fibroids in a minimally invasive manner.
MYOBLATE™ utilizes RFA (radiofrequency ablation), which is a therapeutic form of heat-treatment approach using RFA to safely treat fibroids individually while keeping the uterus intact. According to Ben Ovenden, Business Director of RF Medical, USA, "MYOBLATE™ is the only radiofrequency ablation system for the treatment of uterine fibroids that utilizes a wide range of approaches, unlike existing ablation technology."