RF Medical Mygen m-3004 MYOBLATE
[Image courtesy of RF Medical]

RF Medical announced today that the FDA cleared its Mygen M-3004 generator and specialized electrodes, including Myoblate.

The Korea-based thermal ablation system manufacturer made both products commercially available in the U.S.

According to a news release, the technologies help to modernize the standard of care for minimally invasive practices.

“The world’s medical device market is showing remarkable growth driven by cutting-edge minimally invasive technology and its industrial value is limitless,” said RF Medical CEO Mike Jun. “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.”

Mygen M-3004 enables a combination of monopolar and bipolar modes. RF Medical designed it to deliver radiofrequency energy more effectively and support optimized algorithm modes. These algorithms cover a variety of lesions, depending on size and shape.

The Myoblate system offers a treatment option for women with uterine fibroids. It represents an alternative to hysteroscopy or myomectomy, the company said.

Myoblate uses radiofrequency ablation to safely treat fibroids individually while keeping the uterus intact. RF Medical designed its electrodes for soft tissue coagulation and ablation to treat fibroids in a minimally invasive manner.