Silü® ICM by Suzhou Singular Medical Gains NMPA Approval, Marking China’s First Domestic Breakthrough in ICM Industry|Silü® ICM by Suzhou Singular Medical Gains NMPA Approval, Marking China’s First Domestic Breakthrough in ICM Industry_Company News_News

Singular Medical’s Silü® ICM Secures NMPA Approval, Marking China’s First Domestic Breakthrough in ICM

Recently, the National Medical Products Administration (NMPA) has officially granted marketing registration approval for the Insertable Cardiac Monitor (ICM), an innovative medical device developed by Suzhou Wushuang Medical Equipment Co., Ltd.

According to official NMPA announcements and corporate disclosures, this product is the first domestically developed Insertable Cardiac Monitor (ICM) in China, filling the domestic market gap in the ICM sector. It marks a pivotal breakthrough for home-grown Cardiac Rhythm Management (CRM) devices in cardiac monitoring and diagnosis.

Insertable Cardiac Monitor (ICM) is designed to record subcutaneous electrocardiograms. It is indicated for patients with clinical symptoms, a history of transient symptoms, elevated risk of arrhythmia, or confirmed arrhythmia diagnosis.

Leveraging template matching algorithms, the device identifies and records various arrhythmia episodes. Adopting a low-power front-end circuit design, it features Bluetooth wireless transmission and an extended service lifespan.

Listed below are overseas competing products

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Listed below are overseas competing products

Recurrent unexplained syncope and transient loss of consciousness
Cryptogenic ischemic stroke, screening for occult paroxysmal atrial fibrillation
Paroxysmal palpitations with suspected arrhythmia that cannot be confirmed via short-term examinations
Long-term monitoring for postoperative atrial fibrillation recurrence, and cardiac screening for high-risk populations with malignant arrhythmias
Long-term evaluation of bradyarrhythmias such as long pauses and conduction blocks

Founded in 2017 and headquartered in Suzhou, Singular Medical (“Singular”) focuses on the fields of arrhythmia and heart failure. The company has developed and is developing a full lineup of products covering cardiac screening, rhythm monitoring, remote follow-up systems, the Singular Cloud Platform, electrocardiogram recorders, cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), and various pacing/defibrillation leads for screening, diagnosis, treatment and monitoring workflows. Its business portfolio spans implantable devices, digital healthcare and artificial intelligence technologies.