Baird Medical’s Microwave Ablation System Gains FDA 510(k) Clearance

November 21, 2023—Baird Medical Devices, Inc., a microwave ablation (MWA) medical device developer and provider in China, announced that its subsidiary, Betters (Suzhou) Medical Co., Ltd, has received FDA 510(k) clearance to market its portfolio of MWA systems and disposable MWA needles as regulatory Class II devices in the United States.

Baird Medical’s minimally invasive, thermal energy-based procedure was developed to treat thyroid nodules, breast tumors, and other diseases for which the ablation of soft tissues is indicated.

According to the company, the procedure involves therapeutic microwave energy being safely administered via a device approximately the diameter of a pen. The minimally invasive treatment precisely targets the nodule or tumor being treated, while preserving the surrounding healthy tissue. This precision safeguards the function of the thyroid and reduces the likelihood that a patient will require expensive, lifelong thyroid hormone replacement therapy.

In China, Baird Medical has obtained a Class III medical devices registration certificate for MWA medical devices specifically indicated for thyroid nodules.

The company further noted that both the American Thyroid Association and the European Thyroid Association have published recommended guidelines for the implementation and adoption of the MWA procedure.