Baird Medical announced today that it submitted its disposable microwave ablation (MWA) needle system to the FDA for 510(k) clearance.
Guangzhou, China-based Baird submitted the system in search of an indication for soft tissue microwave ablation. The FDA’s Center for Devices and Radiologic Health (CDRH) accepted the submission last month. Baird’s system already holds approval from China’s National Medical Products Administration, having earned that last month.
The company believes its MWA technology offers advantages over other treatment options, such as open surgery, radiofrequency ablation and cryoablation.
According to a news release, Baird designed its MWA needle system to shorten operation times and speed up patient recovery. It could also reduce procedure costs and post-surgery complications. These advantages, when compared to other approaches, make MWA an attractive option for those seeking minimally invasive, effective treatment, Baird says.
“Minimally invasive and more affordable treatment solutions represent the future,” said Haimei Wu, Baird founder and CEO. “We are pleased to move forward in this as a key part of our global growth and will collaborate closely with the FDA to ensure a smooth and successful submission.”