Baird Medical has received new Class III certificate for its ceramic thyroid ablation needle from China’s National Medical Products Administration (NMPA).
The certificate recognises the needle’s advanced design for treating thyroid nodules, utilising rare earth ceramic materials for improved heat resistance, chemical stability, and electrical insulation.
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Baird Medical’s needle is designed to distribute energy uniformly within the tissue during microwave ablation treatments. This reduces edge heating effects and increases mechanical strength by an estimated 30%.
The improvement in material strength enhances the needle’s flexibility and reliability, crucial for the precision required in delicate surgeries. The needle’s robust construction also minimises the risk of breakage.
Baird Medical founder and CEO Haimei Wu said: “The introduction of the Ceramic Thyroid Ablation Needle signifies another breakthrough innovation in the field of microwave ablation and is a testament to our ongoing commitment to innovation and research.
“We eagerly anticipate the positive impact of this technology by enhancing the patient treatment experiences and saving lives in the years to come.”
The ceramic materials used in the needle optimise heating, allowing for more consistent microwave energy penetration and a 20-30% increase in heating efficiency. High-temperature sintering technology and specialised processes for connecting the needle shaft contribute to this heightened efficiency.
The NMPA’s 2023 updates to the Medical Device Classification Catalog saw Microwave Ablation Devices reclassified from Class II to Class III.
In November 2023, the US Food and Drug Administration (FDA) cleared Baird Medical’s microwave ablation (MWA) system and disposable needles for use in the US.
The technology helps to ablate thyroid nodules, breast tumours and other diseases where soft tissue needs to be removed.
