On June 29, Transtek Medical announced that the first 4G blood glucose meter (TeleBGM2282-G) jointly developed by the company and the Wece Biotech, has officially passed the FDA 510(k) registration in the United States on June 28th, 2023.
Transtek blood glucose meter system consists of blood glucose meter and blood glucose test strips, which can quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from fingertips, and can be used by diabetic patients at home to assist in impoving the effectiveness of diabetes management. Based on the test strips with single-layer 8-electrode and the leading hematocrit correction technology(HCT), 98.8% of the results fall within ± 15%, and its accuracy surpasses the requirements set by the ISO15197:2013/2015. The coefficient of variation (CV) is less than 3%, indicating a high level of precision and reproducibility, which can be compared to the products of industry giants and far exceed most of the competitors in South Korea and Taiwan.
The 4G cellular transmission function of monitor is featured by easy operation, automatic synchronization of measurement results, stable and safe connection, etc. According to the actual measurement data in the US, The average boot time for connecting to the network is 19.39s, and the average time for data transmission is only 1.67s. In addition, the testing efficiency of active antennas exceeds the requirements of ATT in the United States; The testing efficiency of passive antennas is excellent, surpassing industry standards in the low/medium/high frequency range. The good news is that products have passed the SIGIS qualified product list. That is to say, American consumers can directly use FSA/HSA/HRA payment cards to purchase and reimburse products, which will provide American users with greater convenience in purchase and use. It will be an opportunity to expand its market share in the United States in the future.
In recent years, the global prevalence of diabetes has been increasing year by year with an increasing rate of undiagnosed cases, which presents a vast potential for growth in the blood glucose monitoring industry in the future. According to China Insights Consulting, the global blood glucose monitoring market will reach USD 73.8 billion in 2030. We remains its steadfast dedication to providing medical-grade remote health monitoring equipment and services. The above-mentioned blood glucose monitoring products can meet the needs of remote chronic disease management and are used for blood glucose monitoring and management. It will help our expedite the progress of developing new products and entering new markets, strengthening its competitive edge in terms of product quality and market expansion. The FDA registration can significantly enhance the company’s medical device qualification system and play a positive role in accelerating the implementation of the company’s strategies. Furthermore, it is worth anticipating that our new product line including the Bluetooth hearing aids, has also been accepted by the Guangdong Province Drug Administration. All of these demonstrate we commitment to expanding its product portfolio and enhance the ecosystem for health management to inject new momentum into long-term development of healthcare indutry.