Wushuang Medical's Domestic ICM Achieves Zero-to-One Breakthrough with NMPA Approval
Singular Medical
Developer, Manufacturer, and Seller of Cardiac Rhythm Management Products
Recently, SiLv, independently developed by Singular Medical, a company within the Medpark park®The MA01-100 Implantable Cardiac Monitor (ICM) has officially received approval from the National Medical Products Administration (NMPA), obtaining a Class III medical device registration certificate. This product isChina's First Implantable Cardiac Event Monitor (ICM), filling the gap in China's ICM field.
The newly approved ICM product is an innovative masterpiece from Singular Medical, focusing on the field of cardiac rhythm management. It embodies years of dedicated research and technological expertise by the team. This product features fully independent intellectual property rights and was approved through the National Medical Products Administration's (NMPA) green channel for innovative medical devices. The product achieves innovative upgrades in multiple dimensions, including hardware design, algorithm optimization, and data transmission.
? Precision SenseZhi:Capable of precisely capturing ECG signals for various arrhythmias, with clearly visible P-waves; monitoring covers asystole, bradycardia, tachycardia, and atrial fibrillation;
? Massive Storage:Arrhythmia ECG up to 100 minutes, automatic and manual recording with dual channels;
? Remote Follow-up:Supports home monitoring and real-time mobile transmission, enabling physicians to access patients’ ECG data at any time for more timely diagnostic and therapeutic assistance;
The product is primarily indicated for the diagnosis of unexplained syncope and long-term monitoring of patients at risk for arrhythmias, such as those requiring atrial fibrillation surveillance, ensuring that concealed, life-threatening arrhythmias are reliably detected.
Singular Medical
Singular Medical is a deep-tech company dedicated to the research, development, and industrialization of medical devices related to Cardiac Rhythm Management (CRM). Headquartered in the Longshan Science and Innovation Park within Phase I of the Jiangsu Medical Device Technology Industrial Park, the company operates a 2,800-square-meter manufacturing facility and maintains R&D centers in Beijing and Irvine, USA. Starting with Implantable Cardioverter Defibrillators (ICDs)—the most technologically challenging segment in the CRM field—Singular Medical has established a comprehensive CRM technology platform. It is evolving into a full-line supplier of CRM products in China, providing end-to-end solutions for patients with arrhythmias, encompassing monitoring, diagnosis, treatment, and post-operative follow-up.
This approval marks a significant breakthrough for Singular Medical in the field of cardiac rhythm management. It will further enhance the independent innovation and domestic production capabilities of long-term arrhythmia monitoring devices in China, provide clinicians with a broader range of diagnostic and therapeutic options, better meet the long-term monitoring needs of patients with arrhythmias, and hold positive significance for promoting the domestic substitution of high-end medical devices and safeguarding public health.
