Tempus AI Inc. has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-Low EF software. This advanced AI-driven tool is designed to identify patients who may have a low left ventricular ejection fraction (LVEF), which is crucial for diagnosing serious cardiovascular conditions. This clearance marks the second FDA-approved ECG-AI device in Tempus' suite of cardiology tools, following the Tempus ECG-AF. The software is intended for use in clinical settings for patients aged 40 and above who are at risk of heart failure, and it aids in the detection of signs associated with low LVEF. This achievement underscores Tempus' commitment to leveraging AI to enhance precision medicine and patient care.
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