MicroPort® EP's RhythmWatch™ Single Lead ECG Recorder Gains CFDA (Class II) Approval

Shanghai, China – On November 15, RhythmWatch™ Single lead ECG Recorder, in-house developed by Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP"), obtained the approval from China Food and Drug Administration ("CFDA") (Class II). With the aging population, the prevalence rate of arrhythmia is increasing year by year in China. As the most common type of arrhythmia, atrial fibrillation has high morbidity, long duration, high occurrence rate of complex complications, which may cause myocardial ischemia, cardiac failure, or myocardial infarction, leading to disability or death.
Surface ECG is the most convenient way to diagnose arrhythmia, and electrocardiogram recording of arrhythmia attack is an important basis for the diagnosis of arrhythmia. The time of recording ECG signals by ordinary electrocardiograph is very limited, and it is not easy to capture for paroxysmal arrhythmia. Since the traditional Holter has many limitations, such as patient has to wear it in the hospital, poor comfort, and needed reservation due to a limited number in each hospital, it is not convenient for patients.
RhythmWatch™ Single-lead ECG Recorder is composed of mobile recorders, host software, mobile terminal software and server front-end software. It is designed for medical institutions to collect, record and send ECG signals for patients. RhythmWatch™ Single-lead ECG Recorder is designed in patch style, so patients can wear it for a long time with continuous acquisition of ECG signal. The ECG signals could be replayed with the software. The device could communicate with mobile APP, showing the real-time electrocardiogram, and it can provide immediate view and auxiliary diagnosis for physicians. Through the server front-end software, it can not only make the electrocardiogram display in real time, but also realize the sharing of ECG data. The launch of this device is expected to improve the efficiency of diagnosis and treatment for outpatients, and ease the burden for patients who need follow-up after discharge as well.
RhythmWatch™ Single lead ECG Recorder is the first portable ECG monitoring product of MicroPort® EP launched in the China market. Its launch marks another step forward for MicroPort® EP in building a complete cardiac EP solution platform. Dr. Yiyong Sun, President of MicroPort® EP, said: "It is well acknowledged that smaller, wireless and smarter electrophysiological medical hardware has a promising future in the era of mobile internet. In the future, MicroPort® EP will continue to combine the professional medical service with modern IT technology to develop more innovative products to benefit more patients and doctors."