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Baird Medical Gains FDA Clearance for Marketing Microwave Ablation System in the United States

Wednesday, November 22, 2023

Baird Medical Devices, a prominent developer and provider of microwave ablation ("MWA") medical devices in China, recently announced a significant milestone. Its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received approval from the U.S. Food and Drug Administration (FDA) under Section 510(K) to market its Microwave Ablation Systems and Disposable Microwave Ablation Needles as Class II devices in the United States.

Thyroid nodules affect a substantial portion of the U.S. population, ranging from 30% to 50%. Predominantly observed in women and increasing with age, over half of women aged 60 or older will develop a thyroid nodule. Historically, treatments involving excision or therapy have been associated with patient discomfort and inconvenience. In response, Baird Medical has capitalized on recent technological advancements to introduce a minimally invasive, thermal energy-based procedure to address thyroid nodules, breast tumors, and other soft tissue diseases requiring coagulation (ablation).

Distinguishing itself from traditional methods, Baird's approach eliminates the necessity for surgery, thereby reducing complications, risks, and scarring for the majority of patients. The Procedure involves the precise administration of therapeutic microwave energy through a device approximately the size of a pen. This minimally invasive treatment precisely targets the specific nodule or tumor while preserving surrounding healthy tissue, a critical aspect in safeguarding thyroid function and minimizing the likelihood of patients requiring costly, lifelong thyroid hormone replacement therapy.

The positive outcomes associated with the Procedure have garnered recognition from authoritative bodies such as the American Thyroid Association and the European Thyroid Association, leading to the publication of recommended guidelines for its implementation and adoption. To further promote awareness among physicians and patients, organizations like The North America Society for Interventional Thyroidology have been established, emphasizing the existence of a minimally invasive solution for thyroid disease treatment.

Source: prnewswire.com

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