Daying Medical's digital breast tomosynthesis X-ray machine has been approved for Class III medical device registration.
Recently, Daying Medical (Zhongshan) Co., Ltd. (hereinafter referred to as: Daying Medical), an enterprise in the health base park, obtained the Class III medical device registration certificate for its digital breast tomosynthesis X-ray machine product.Breast X-ray photography is an internationally recognized method for breast cancer screening. The latest generation of breast cancer screening technology, Digital Breast Tomosynthesis (DBT), is currently the most advanced technology in the world, used for three-dimensional imaging in breast cancer screening. It can reduce or eliminate missed diagnoses and misdiagnoses caused by tissue overlap and structural noise in traditional two-dimensional breast X-ray photography. Currently, the Chinese 3D digital breast machine market is still in its infancy and mainly relies on imports. Daying Medical's products have largely filled the gap in new technologies for breast cancer screening.
Located in the Huojue Smart Health Town, Daying Medical is a project that the health base focused on introducing in 2018. It mainly engages in the research, development, production, and sales of high-end medical imaging equipment for breast cancer, lung cancer, and other cancer screenings. It officially started production in 2020. The company founder, Dr. Wu Tao, is an early inventor and researcher of DBT. His work on DBT won the AAPM (American Association of Physicists in Medicine) Young Scientist Award, the 2004 Sylvia Sorkin Greenfield Award for the best academic paper in Medical Physics, and he developed the world's first DBT system in 1997, making pioneering contributions to technological and clinical industrialization. This DBT prototype was transferred to the Russel Museum of Medical History and Innovation in Boston in 2015. Dr. Wu Tao founded Daying Medical in 2017, aiming to "build products for breast cancer screening and diagnosis in China based on evidence-based medicine and the world's best standards." With this vision, the breast X-ray machine products developed by his team have obtained multiple invention patents and innovation awards in China. Previously, the company's Class II (2D) products obtained the Class II medical device registration certificate on February 28, 2020. The Class III (3D) product approved this time is a functional upgrade of the Class II product. It is understood that compared with imported equipment from abroad, Daying Medical's products have many advantages. They have achieved data acquisition and image algorithm optimization for the dense breast data of Chinese women, showing a significant technological improvement compared to imported equipment.Daying Medical's products have broad market prospects. With the increasing demand for breast cancer screening year by year, the breast cancer screening task is gradually expanding from tertiary hospitals to primary hospitals, with primary hospitals further undertaking the responsibility of breast cancer screening and popularization. Currently, many large hospitals in Beijing, Guangdong, Hebei, and other places have begun to use digital breast machines researched and produced by Daying Medical for breast cancer screening, replacing imported medical equipment.Daying Medical's DBT product also won the 7th China Innovation and Entrepreneurship Competition National Excellent Enterprise Award in 2018, the 3rd prize in the provincial finals of the 8th China Innovation and Entrepreneurship Competition in 2019, the 2019 German Red Dot Design Award, the second prize in the 1st HICOOL Global Entrepreneurship Summit and Entrepreneurship Competition in 2020, and the recognition of the Zhongshan City "DBT Breast Cancer Screening Entrepreneurial Team".
