Wushuang Medical's Innovative ICM 'Sili® MA01-100' Receives NMPA Class III Approval
Singular Medical
Developer, Manufacturer, and Seller of Cardiac Rhythm Management Products
Recently, the Silü® MA01-100 Implantable Cardiac Monitor (ICM), independently developed by Singular Medical, has officially received approval from the National Medical Products Administration (NMPA) and successfully obtained a Class III medical device registration certificate.
This approval marks a significant breakthrough for Singular Medical in the field of cardiac rhythm management, further enhancing independent innovation and domestic production capabilities in China for long-term arrhythmia monitoring devices. It provides clinicians with a broader range of diagnostic and therapeutic options, better meets the long-term monitoring needs of patients with arrhythmias, and holds positive significance for promoting the domestic substitution of high-end medical devices and safeguarding public health.
Breakthrough in Independent Innovation, Filling the Domestic Gap
The ICM product recently approved represents Singular Medical’s innovative breakthrough in the field of cardiac rhythm management, embodying years of dedicated R&D efforts and technological expertise by the team. This product features fully independent intellectual property rights and was approved through the National Medical Products Administration’s green channel for innovative medical devices. It achieves innovative upgrades across multiple dimensions, including hardware design, algorithm optimization, and data transmission.
✅ Precision Sensing: 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 recording for up to 100 minutes, with dual-channel automatic and manual recording;
✅ 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 promptly detected.
Clinical findings published in the Chinese Journal of Cardiac Arrhythmias
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Singular Medical’s Pre-Market Clinical Study Results for the Sili® MA01-100 Model ICM Published for the First Time in ChinaArrhythmiaTop-tier journal in the field—Chinese Journal of Cardiac Arrhythmias.
This publication not only comprehensively validates the product’s superior performance and reliable safety profile with detailed data, but also provides robust evidence-based support for the clinical adoption of domestically produced implantable ECG monitoring devices, marking the formal recognition of Chinese innovative diagnostic and therapeutic equipment by the highest academic authority in the field of arrhythmia management in China.
Clinical Research Published in Internationally Authoritative Journals
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Pre-market clinical trial results of the Singular Medical Silu® MA01-100 ICM have been published in the international journal Pacing and Clinical Electrophysiology (PACE).
As one of the most influential academic platforms in the field of cardiac pacing and clinical electrophysiology, the publication of this work in PACE not only marks the debut of China’s independently developed implantable cardiac monitor (ICM) on the mainstream international academic stage, but also signifies that its clinical value has gained high recognition from global peers, representing a significant milestone in the internationalization of domestically produced cardiac rhythm management devices.
