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Investing.com -- Tempus AI , Inc. (NASDAQ:TEM) stock rose 3% on Wednesday after the precision medicine technology company announced it received 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECG-Low EF software.
The AI-powered software is designed to identify patients who may have a low left ventricular ejection fraction (LVEF), which measures the percentage of blood pumped out with each heartbeat. A reduced LVEF can indicate serious cardiovascular conditions including heart failure, cardiomyopathy, or damage from a prior heart attack.
This marks the second FDA-cleared ECG-AI device in Tempus’ cardiovascular product suite, following its previously cleared Tempus ECG-AF solution. The new software analyzes resting, non-ambulatory 12-lead ECG recordings to detect signs associated with an LVEF of 40% or less.
"With Tempus ECG-Low EF, we’re adding another powerful tool to the hands of clinicians to help them identify patients at risk for serious cardiovascular conditions much earlier in their care journey," said Brandon Fornwalt, Senior Vice President of Cardiology at Tempus.
The software is intended for use on clinical diagnostic ECG recordings collected at healthcare facilities from patients 40 years or older who are at risk of heart failure. This includes patients with conditions such as atrial fibrillation, aortic stenosis, diabetes, hypertension, and ischemic heart disease.
Tempus emphasizes that the software is not a stand-alone diagnostic tool and results should be interpreted alongside other diagnostic information, including original ECG recordings, other tests, and the patient’s symptoms and clinical history.
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