BSD Medical has received FDA review questions regarding the 510(k) submission, which the company has filed for premarket clearance of the Phase II MicroThermX Microwave Ablation System (MTX-180), for ablation of soft tissue.
BSD Medical said that the FDA clearance for the 510(k) submission will authorise commercial distribution of the MTX-180 in the US and allow the company to provide an optimised system targeted to the growing therapeutic interventional oncology market.
The MTX-180 employs precision-guided microwave energy to ablate (destroy) soft tissue using a single-patient-use disposable antenna. The MTX-180 was developed to provide treatments as a stand-alone therapy.
Harold Wolcott, president of BSD, said: “We expected questions from the FDA as a routine part of the 510(k) submission review process. We plan to provide a timely response to the questions from the FDA. While we cannot predict the ultimate outcome or when the review will be completed, we are optimistic about the outcome.”
BSD Medical develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radio frequency (RF) and microwave energy. BSD’s product lines include both hyperthermia and ablation treatment systems.