Tempus AI (TEM) stock is soaring 5.21% in pre-market trading on Wednesday following the announcement that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-Low EF software. This 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.

The FDA clearance marks a significant milestone for Tempus AI, as it represents the second FDA-approved ECG-AI device in the company's suite of cardiology tools, following the previously approved 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, aiding in the detection of signs associated with low LVEF.

This achievement underscores Tempus AI's commitment to leveraging artificial intelligence to enhance precision medicine and patient care. The positive market reaction reflects investor confidence in the company's innovative approach to healthcare technology and its potential impact on cardiovascular risk detection. As Tempus AI continues to expand its AI-driven healthcare solutions, the stock may see further interest from investors looking to capitalize on advancements in medical technology.