Recently, the National Medical Products Administration approved the registration application for the implantable electrocardiogram event monitor submitted by Singular Medical.
This product consists of an Implantable Cardiac Monitor (ICM) and a patient activator. It is designed to record subcutaneous electrocardiograms and is indicated for patients who are at increased risk of arrhythmias or have been diagnosed with arrhythmias, particularly those experiencing clinical symptoms or a history of transient symptoms.
This product is the first domestically developed implantable cardiac monitor (ICM) in China, filling the gap in the ICM field in our country.
The drug regulatory authorities will strengthen post-market supervision of the aforementioned products to ensure the safety of medical devices for patients.
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ComeSource: National Medical Products Administration
