The approval follows the registration of the first Class III thyroid MWA device and its accessories in China on November 18, 2021, by Nanjing Changcheng Medical Equipment Company Limited, a subsidiary of Baird Medical
This accomplishment marks the first independently registered product of its kind in China. (Credit: Sam Moghadam Khamseh on Unsplash)
Baird Medical Investment Holdings, a leading microwave ablation medical device developer and provider in China, announced today that the Company’s independently developed and produced disposable MWA needle for the treatment of benign thyroid nodules received approval from China’s National Medical Products Administration on July 13, 2023. The approval follows the registration of the first Class III thyroid MWA device and its accessories in China on November 18, 2021, by Nanjing Changcheng Medical Equipment Company Limited, a subsidiary of Baird Medical. This accomplishment marks the first independently registered product of its kind in China.
The Company expects the acquisition of the Class III certificate for the MWA needle will simplify sales processes and streamline the admission procedure for Baird Medical’s MWA needles. It will also expand the range of available specifications and models, allowing the company to customize its sales strategy for different disease types.
Baird Medical has actively complied with the policy and regulatory requirements set by the NMPA, conducting a comprehensive series of activities related to the Class III registration of MWA products. These included design enhancements and extensive efficacy and safety experiments, including animal and clinical trials, to help ensure the product’s safety and quality prior to launch. By offering safe, advanced MWA products for the treatment of thyroid diseases, Baird Medical aims to provide minimally invasive treatment options and solutions for patients. These solutions are particularly valuable to those with large thyroid cysts, nodular goiters, and individuals who are unable to undergo surgery.
Minimally invasive ablation technology for thyroid nodules has gained significant recognition over the past two decades due to its many potential applications. Thyroid nodule ablation technology has continuously advanced during that time, and its safety and effectiveness are well-established. Compared to surgical procedures, thyroid ablation technology offers advantages such as precise local anesthesia and real-time ultrasound-guided tumor ablation. Potential benefits for patients include reduced operation times, lower costs compared to open surgery, fewer complications, reduced damage to surrounding tissues, avoiding surgical scars, and effectively preserving thyroid function post-surgery. Thermal ablation is currently endorsed as one of the treatment options for benign thyroid nodules by multiple international and domestic guidelines.
Ms. Haimei Wu, Founder and CEO of Baird Medical, commented, “our recent approval from China’s National Medical Products Administration for our Class III disposable MWA needle is a testament to our unwavering commitment to scientific rigor, quality, and safety. We are proud of the strides we have made as a leading force in the development and provision of MWA devices. At Baird Medical, we remain steadfast in our pursuit of transformative solutions that offer minimally invasive, efficient, and more affordable treatment options for patients. Our success in developing this solution is another step in our continued journey to provide the highest standard of care to patients worldwide.”
Source: Company Press Release