Tingsn Medtech Secures FDA Approval for Proprietary Intracardiac Echocardiography (ICE) System, Paving the Way for Global Expansion

The TINGSN ICE System, which has been approved by the FDA this time, consists of two core components:

• TINGSN FINDERS 2 

TINGSN FINDERS 2 is a portable color Doppler ultrasound diagnostic device. As the "brain" of the system, its high-definition imaging platform and intelligent analysis algorithms provide accurate imaging data support for clinical use.

Figure 1 TINGSN FINDERS 2

• TINGSN Sonic Eyes 10 Eco

TINGSN Sonic Eyes 10 Eco is an intracardiac echocardiography diagnostic catheter with a diameter of only 10F. The probe features a miniaturized design, allowing it to reach the interior of the heart through blood vessels. It provides real-time dynamic imaging of cardiac structures and blood flow, offering "visual navigation" for interventional procedures.

Figure 2 TINGSN Sonic Eyes 10 Eco

Since its establishment in 2017,TINGSN Technology Focuses on Technological Innovation in Cardiac Electrophysiology and Structural Heart Disease with Ultrasound Imaging、Mapping, and the combined application of ablation energy,Committed to enabling more patients with heart disease to receive more effective treatmentOver the years, TINGSN has achieved several significant breakthroughs in ICE. The TINGSN ICE system, with its core advantages in image clarity, operational convenience, and performance stability, has not only quickly gained a strong foothold in the Chinese market but also become the first domestically produced ICE product to obtain FDA approval, demonstrating that China's R&D capabilities in high-end medical devices have entered the ranks of international leaders.

For a long time, the global ICE market has been monopolized by a few international giants, and clinical institutions in China have had to rely on high-priced imported equipment. The breakthrough by TINGSN has torn open this monopolistic pattern for the first time. Data shows,The Global ICE Market Size Breaks Through More Than One Billion US Dollars in 2024``, and maintains rapid growth. The entry of TINGSN not only brings diversified choices to clinical doctors and reduces medical costs, but also breaks the preconceived notion that "domestically produced equipment is inferior to imported ones" with its solid technical performance. 

FDA certification, known for its stringent standards, is hailed as the "passport" to the global medical device market. The approval of TINGSN's ICE system by this certification signifies that its safety and efficacy have received the highest international recognition, paving the way for entry into the world’s largest single healthcare market. This achievement is not only a milestone for TINGSN Technology but also sets a benchmark for Chinese medical device companies "going global," showcasing the innovative vitality of China's medical technology to the world.

FDA certification and approval,It is a crucial step for China's intracardiac echocardiography technology to go global.This is the best reward for the team's commitment to independent innovation. TINGSN will take this as a starting point, accelerate its global layout, and allow China's intelligent manufacturing to benefit more patients in other countries. At the same time, it will continue to focus on technology research and development, promoting advancements in the field of cardiac interventional imaging. As a company dedicated to providing solutions for the diagnosis and treatment of heart diseases, TINGSN Technology takes "Innovation Leads, Carefully Guarding" as its mission. Its product line includes 2D ICE systems, 4D ICE systems, and 3D electrophysiological mapping systems, gradually growing into an important force in the global cardiac intervention field.