The FDA clearance designates Baird Medical Devices’ MWA Systems and MWA Needles as regulatory Class II devices in the US
Baird Medical Devices said that its subsidiary Betters Medical has received the 510 (K) clearance from the US Food and Drug Administration (FDA) for marketing its range of Microwave Ablation (MWA) Systems and Disposable Microwave Ablation Needles.
Based in Guangzhou, China, Baird Medical Devices is engaged in manufacturing and providing MWA medical devices.
The FDA clearance designates its MWA Systems and MWA Needles as regulatory Class II devices in the US.
Baird Medical Devices founder and CEO Haimei Wu said: “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 US.
“Based on our market research, we estimate that the US presents a market opportunity of $1.6bn for MWA systems alone.”
According to Baird Medical Devices, traditionally, patients undergoing excision or therapy faced discomfort and inconvenience. In a departure from these conventional methods, Baird Medical is said to have created a minimally invasive procedure which utilises thermal energy.
This approach from the Chinese firm is designed for treating conditions such as thyroid nodules, breast tumours, and other diseases requiring the coagulation of soft tissues. By eliminating the necessity for surgery, the company’s method is claimed to reduce the related complications, risks, and scarring for the majority of patients.
The company stated that its procedure involves the safe delivery of therapeutic microwave energy through a device about the size of a pen.
The minimally invasive treatment specifically focuses on the targeted nodule or tumour, thereby preserving the surrounding healthy tissue with precision. This accuracy helps protect thyroid function and lowers the chances of patients needing expensive, long-term thyroid hormone replacement medication, said the company.