Regulatory Notice
Not available for clinical use in the United States
ECG Buddy_LVD is currently undergoing the FDA clearance process.
It is not approved or cleared for clinical use in the US.
All product details are subject to change pending regulatory review.
LV Dysfunction (EF<40%)
Identifies patients at elevated risk of heart failure and adverse cardiac events in seconds
ECG Buddy_LVD draws on the same core model powering ARPI’s CE MDR approved and MFDS-approved ECG Buddy, already in active daily clinical use globally.
