Baird Medical, leading microwave ablation (MWA) medical device developer and provider in China, has announced that its subsidiary, Betters Medical, has received clearance from the US Food and Drug Administration (FDA) under Section 510k, to begin marketing its portfolio of MWA systems and disposable MWA needles as regulatory class II devices in the USA.
Thyroid nodules occur among 30% to 50% of the population of the USA. Like most thyroid conditions, nodules are more common among women than men, with an increased incidence observed with advancing age. By the age of 60, more than half of women will have developed a thyroid nodule.
Historically, treatment involving excision or therapy resulted in discomfort and inconvenience for patients. In contrast to these traditional approaches, Baird Medical has leveraged significant recent technological advances to develop a minimally invasive, thermal energy-based procedure to treat thyroid nodules, breast tumours, and other diseases for which the coagulation of soft tissues is indicated. Baird Medicals’ approach, they state, eliminates the need for surgery, thereby mitigating associated complications, risks, and scarring for the majority of patients.
The press release states that, during the procedure, therapeutic microwave energy is safely administered via a device approximately the diameter of a pen. This minimally invasive treatment precisely targets the nodule or tumour being treated, while preserving the surrounding healthy tissue. This precision is crucial, as it safeguards the function of the thyroid and reduces the likelihood that a patient will require expensive, lifelong thyroid hormone replacement therapy.
In light of the increasing scientific evidence demonstrating positive outcomes associated with the expanded availability of MWA, both the American Thyroid Association (ATA) and the European Thyroid Association (ETA) have published recommended guidelines for its implementation and adoption. Physician associations, such as the North America Society for Interventional Thyroidology (NASIT), have been established to raise awareness among physicians and patients that a minimally invasive solution exists for treating thyroid disease.
Haimei Wu, founder and CEO of Baird Medical, commented: “Attaining FDA clearance represents a significant milestone in our geographical expansion. This clearance grants us the ability to market our portfolio of MWA systems and disposable needles in the USA. Our team are ready to expand our market reach and deliver the much-needed benefits of our minimally invasive MWA procedure to patients across [the USA].”
