Two Innovative Medical Devices Approved by China's NMPA
Singular Medical
Developer, Manufacturer, and Seller of Cardiac Rhythm Management Products
Skynor Medical
Vascular Minimally Invasive Intervention Product Developer
Source: National Medical Products Administration
Recently, the National Medical Products Administration approved the registration applications for the implantable cardiac event monitor from Suzhou Singular Medical Equipment Co., Ltd. and the intracranial stent from Skynor Medical (Shanghai) Co., Ltd.
Implantable Cardiac Event Monitor
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 exhibit clinical symptoms or have experienced transient symptoms, are at increased risk of arrhythmia, or have been diagnosed with arrhythmia.
This product is the first domestically developed implantable cardiac monitor (ICM) in China, filling the gap in the ICM field in our country.
Intracranial Stent
This product consists of a stent and a delivery system, designed to be used in conjunction with embolization devices for the treatment of wide-necked saccular aneurysms in the anterior circulation of the intracranial arteries. The stent features a closed-cell helical wire interlocking design, a closed-loop structure, and full radiopacity, intended to provide excellent flexibility and wall apposition, allow for recapture and repositioning, and ensure accurate placement.
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