US FDA clears Mygen M-3004 and Myoblate radiofrequency ablation system

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RADIOFREQUENCY
Mygen M-3004 generator

RF Medical is a Korean thermal ablation system manufacturer and the creator of the Mygen M-3004 generator and specialised electrodes including Myoblate. Both of these products have been cleared by the US Food and Drug Administration (FDA) and are now commercially available in the USA.

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. Jun is confident that Mygen and Myoblate will empower US-based medical facilities and practices, and will modernise the standard of care for minimally invasive practices in the USA.

According to 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 research and development.”

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 optimised 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 utilises radiofrequency ablation to safely treat fibroids individually while keeping the uterus intact. According to Ben Ovenden, Business Director of RF Medical, USA, “Myoblate is the only RFA system for the treatment of uterine fibroids that utilises a wide range of approaches, unlike existing ablation technology.”


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