On December 22, 2023, the first domestically produced implantable cardiac monitor (ICM) - Singular Medical's SiLu ICM - commenced its prospective, multicenter confirmatory trial. The trial, led by Professor Su Yangan, Vice President of the Electrophysiology and Pacing Branch of the Chinese Medical Association and Zhongshan Hospital affiliated with Fudan University, marked a significant milestone by enrolling its first participant on the day of the launch. This event signifies China's emerging strength in the field of implantable cardiac monitoring.

Cardiovascular diseases are chronic ailments that pose a serious threat to public health and quality of life. Over the past 30 years, the incidence, death rate, and disability-adjusted life years of cardiovascular diseases in China have surged dramatically, particularly between 2010 and 2019, highlighting the challenges in preventing and treating these conditions. In the diagnosis and treatment of cardiovascular diseases, prevention is paramount, and early screening and diagnosis are key strategies—aligning with the national healthcare reform's focus on chronic disease prevention and management.

The ICM is a vital tool for the early screening and diagnosis of cardiovascular diseases. It is an electronic device implanted under the skin, capable of continuously monitoring abnormal cardiac electrical activity. It is widely used in the management of syncope, cryptogenic stroke, atrial fibrillation screening, and pre- and post-operative management of atrial fibrillation, offering immense clinical value. In 2021, over 310,000 units were implanted in the United States, with China in the early stages of widespread adoption.

Suzhou Singular Medical Co., Ltd.'s SiLu ICM features industry-leading storage capacity and introduces innovative waveform template-assisted diagnostics. By enabling Bluetooth connectivity, it overcomes barriers in home monitoring and timely data transmission. After thorough pre-clinical research, it has become the first ICM in China to enter the confirmatory trial phase.

The Department of Cardiology, specializing in arrhythmia at Zhongshan Hospital affiliated with Fudan University, is a leading professional group in China. Under the leadership of Academician Ge Junbo, this group has done extensive work in the field of arrhythmia diagnosis and treatment, particularly in the clinical application and development of new technologies. The first participant enrolled in this study was an elderly woman with unexplained syncope. Professor Su Yangan's team skillfully and swiftly completed the surgery, producing excellent research data. The participant was discharged the next day. The entire process demonstrated scientific rigor, efficient progress, and high-quality implementation, fully showcasing Zhongshan Hospital's pragmatic capabilities in clinical research.

The confirmatory clinical trial of Singular Medical's SiLu ICM aims to verify the safety and efficacy of the first domestically produced ICM, strengthening the bond between clinical application needs and research and development enterprises. Time rewards those who work diligently, and Singular Medical will continue to commit to expanding the development of sophisticated medical devices for arrhythmia management, bringing homegrown solutions to more patients.

Company Introduction

Suzhou Singular Medical Co., Ltd. is a high-tech company focused on the development and industrialization of medical devices for Cardiac Rhythm Management (CRM).The company's headquarters are located in the Medical Device Industrial Park within the High-Tech Zone of Suzhou, with a 2,800 square meter manufacturing facility. Singular Medical also has research and development centers in Beijing, Irvine (USA), and Minnesota (USA). Starting with the most technically challenging product in the CRM field, the Implantable Cardiac Defibrillator (ICD), Singular Medical has built a comprehensive CRM technology platform. The company is growing to become a supplier of a full range of CRM products in China, capable of providing a complete solution for patients with cardiac arrhythmias, ranging from monitoring and diagnosis to treatment and postoperative follow-up.

Expert Introduction

Ge Junbo
Affiliated with Zhongshan Hospital, Fudan University

Ge Junbo is an Academician of the Chinese Academy of Sciences and the Director of the Department of Cardiology at Zhongshan Hospital affiliated with Fudan University. He currently serves as the President of the Cardiovascular Internal Medicine Physicians Branch of the Chinese Medical Doctor Association, President of the China Cardiovascular Health Alliance, Director of the National Clinical Research Center for Radiation and Treatment, President of the Innovative College of the China Cardiovascular Innovation Club, Director of the Shanghai Cardiovascular Clinical Medical Center, Director of the Shanghai Cardiovascular Disease Research Institute, President of Anhui Provincial Hospital, Dean of the Biomedical Research Institute of Fudan University, Dean of the Pan-Vascular Medicine Research Institute of Fudan University, President of the Pan-Vascular Foundation of Fudan University, Director of the “Cardiovascular Interventional Treatment Technology and Equipment” Engineering Research Center of the Ministry of Education, a member of the Chinese Academy of Medical Sciences, a council member of the American Society of Cardiovascular Angiography and Interventions, an international advisor to the American College of Cardiology, an executive director of the World Heart Federation, honorary president of the World Chinese Cardiologists Association, and a visiting professor at Columbia University. He has been honored with titles such as "Yangtze River Scholar", "Science and Technology Elite", "National May Day Labor Medal", "Tan Jiazhen Life Science Award", and "Bethune Medal". He is internationally recognized for discovering specific ultrasonographic diagnostic indicators of myocardial bridging, the "crescent sign" and "finger-tip sign", led the development of China's first degradable coating coronary stent, pioneered the "retrograde wire kissing technique" at the American TCT conference as the first scholar in China, and successfully performed China's first percutaneous aortic valve implantation, percutaneous mitral valve repair, and percutaneous pulmonary artery shaping surgery. He has undertaken more than 20 national and provincial scientific research projects including the "863" Program, National Outstanding Youth Fund, and key projects, published over 150 SCI papers as the corresponding/first author, and received more than 10 national and provincial science and technology awards as the first completor. He is the chief editor of the national unified textbook "Internal Medicine" of the Ministry of Health, "Intravascular Ultrasound", and other Chinese and English academic works, totaling 6. He is a specially-appointed professor of the "Yangtze River Plan", a national "May Day" labor medalist, and has long been committed to optimizing the treatment strategies and technological innovations for coronary artery diseases. He has achieved a series of results in the fields of intravascular ultrasound technology, development of new coronary stents, intervention strategies for complex coronary artery diseases, and cellular therapy for coronary diseases. He has undertaken more than 20 national and provincial scientific research projects, published more than 300 SCI or SCI-E papers as a corresponding author, edited 1 English monograph, 19 Chinese monographs, served as the chief editor of the 8th edition of "Internal Medicine" and the 15th edition of "Practical Internal Medicine", the editor-in-chief of Cardiology Plus, and the associate editor-in-chief of Herz. He has received more than 10 scientific awards including the second prize of National Science and Technology Progress, the second prize of National Technological Invention, the first prize of Scientific and Technological Progress of the Ministry of Education, the second prize of Chinese Medical Science and Technology, the first prize of Shanghai Science and Technology Progress, and the Shanghai Science and Technology Meritorious Award.

Su Yangan

Zhongshan Hospital affiliated with Fudan University

Su Yangan is the Director of the Electrocardiogram Department and the head of the Cardiac Pacing Subspecialty at Zhongshan Hospital affiliated with Fudan University. He holds the positions of Professor, Chief Physician, and Doctoral Supervisor. Additionally, he is the Vice President of the Electrophysiology and Pacing Branch of the Chinese Medical Association, the Leader of the Cardiac Pacing Group within the same branch, the President of the Shanghai Society of Cardiac Rhythm, the Deputy Editor-in-Chief of the Chinese Journal of Arrhythmias, and a member of the Heart Rhythm Society (HRS) in the United States with the designation FHRS (Fellow of the Heart Rhythm Society).