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FDA Approves AI-Powered ECG Devices from TempusAI and AliveCor, Including 510(k) Clearance

Jun 27, 2024, 10:22 AM

The U.S. FDA has recently approved several advanced electrocardiogram (ECG) devices that leverage artificial intelligence (AI) to enhance cardiac care. Among these, TempusAI's ECG-AF device received 510(k) clearance for its AI capabilities to identify patients at increased risk of atrial fibrillation (AF). This marks the first FDA clearance for an AF indication in the category of cardio machine learning-based notification software. Additionally, AliveCor's Kardia 12L ECG System, also AI-powered, has been cleared by the FDA. This 12-lead ECG system aims to expand access to accurate heart data, particularly in resource-limited and rural areas. Wellue's single-channel, 24-hour ECG recorder offers continuous monitoring and real-time tracking through a smartphone app, providing AI-powered analysis and report generation. Furthermore, a small portable electrocardiogram device has been approved to detect heart attacks and other cardiac conditions.