Lepu Medical Receives FDA Approval For Registration of AI-Based ECG Diagnostic System

Chinese device maker Lepu Medical Technology Co. has received approval from the U.S. Food and Drug Administration for the registration of an electrocardiogram analysis and diagnosis system based on artificial intelligence. The Beijing-based firm's Carewell Healthcare subsidiary developed the product, named AI ECG Platform, which covers major cardiovascular diseases, Lepu said in a statement. AI ECG Platform's diagnostic accuracy for a variety of heart diseases is over 95 percent, a similar level to ECG medical experts and it is capable of outperforming specialists for the diagnosis of some complex cases, the firm added. The company has applied for more than a dozen Chinese and international patents related to the technology. Lepu aims to promote the use of the product in primary hospitals and clinics which lack professional cardiologists.