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December 19, 2022
RF Medical’s Mygen M-3004 and Myoblate Radiofrequency Ablation System Cleared by FDA
December 19, 2022—RF Medical Co., Ltd., a Korea-based manufacturer of thermal ablation systems, recently announced FDA clearance of the company’s Mygen M-3004 generator and Myoblate radiofrequency ablation system, which are now commercially available in the United States.
According to the company, the Mygen M-3004 enables a combination of monopolar and bipolar modes. In addition to delivering radiofrequency energy more effectively, it supports optimized algorithm modes for use in a variety of lesions depending on their size and shape.
The Myoblate system’s electrodes are intended for soft tissue coagulation and ablation to treat uterine fibroids, providing a less-invasive and more patient-friendly alternative to hysteroscopy or myomectomy, stated the company.
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