Congratulations to Lepu's AI-ECG Tracker for obtaining Class III registration approval from the State Drug Administration
Lepu's AI-ECG Tracker is another AI class III certificate approved by the State Drug Administration after the ECG analysis software (AI-ECG Platform), OmniECG B120 artificial intelligence electrocardiograph machine, and OmniECG C120 artificial intelligence electrocardiograph machine.
AI-ECG Tracker obtained EU CE certification in November 2019, US FDA approval in March 2020, and NMPA Class III certification in September 2022. It is the world's first dynamic ECG artificial intelligence product to obtain three certificates, and the world's first ECG artificial intelligence product to obtain three certificates is Lepu Cloud Intelligent's AI-ECG Platform.
The functional modules of AI-ECG Tracker include: system management client, doctor diagnosis client, and ECG analysis server.
This product can be used in conjunction with Lepu Cloud Intelligent terminal equipment. In view of the large workload of Holter reading, it assists practitioners in analyzing Holter data, which is faster, more accurate and more comprehensive.
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Good News | Lepu Cloud Intelligent AI-ECG Tracker Was Approved by National Medical Products Administration
On September 1, AI Cloud Intelligent's "dynamic ECG analysis software AI-ECG Tracker (National Equipment Note 20223211142)" was approved by the State Drug Administration for Class III registration. Previously, AI-ECG Tracker has obtained EU CE certification in November 2019, and was approved by the US FDA in March 2020.
Following the ECG analysis software (AI-ECG Platform), the OmniECG B120 artificial intelligence electrocardiograph, and the OmniECG C120 artificial intelligence electrocardiograph, the cloud intelligent dynamic electrocardiographic analysis software (AI-ECG Tracker) is the fourth national drug supervision of Lepu. Agency-approved AI Category III product.
The functional modules of AI-ECG Tracker include: system management client, doctor diagnosis client, and ECG analysis server.
Our products can be used in conjunction with Lepu Cloud Intelligent terminal equipment. In view of the large workload of dynamic ECG reading, the product can assist practitioners in analyzing dynamic ECG data, which is faster, more accurate and more comprehensive.