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CHICAGO - Tempus AI, Inc. (NASDAQ:TEM), a $9.68 billion healthcare technology company showing impressive revenue growth of 43% over the last twelve months, announced Wednesday it has received 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECG-Low EF software, which uses artificial intelligence to identify patients who may have a low left ventricular ejection fraction. According to InvestingPro analysis, the company is currently trading above its Fair Value despite recent market enthusiasm.
The newly cleared software becomes the second FDA-cleared ECG-AI device in Tempus’ cardiovascular diagnostic portfolio, joining Tempus ECG-AF. The technology analyzes resting, non-ambulatory 12-lead ECG recordings to detect signs associated with having an ejection fraction of 40% or less. The company’s expansion in medical diagnostics comes amid a strong market performance, with the stock showing a remarkable 61% gain over the past six months.
Ejection fraction measures the percentage of blood pumped out with each heartbeat, with reduced levels potentially indicating serious cardiovascular conditions including heart failure, cardiomyopathy, or damage from a prior heart attack.
"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 at risk of heart failure. This includes patients with conditions such as atrial fibrillation, aortic stenosis, and diabetes.
Tempus emphasized that the software is not intended as a stand-alone diagnostic tool and should be used in conjunction with other diagnostic information. A positive result may suggest the need for further clinical evaluation to establish a diagnosis of low LVEF.
According to the company’s press release statement, the technology aims to help identify at-risk patients earlier in their care journey. While operating with moderate debt levels, Tempus continues to invest in growth initiatives. For deeper insights into Tempus’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed financial metrics for over 1,400 US stocks.
In other recent news, Tempus AI, Inc. announced the expansion of its Tempus Next platform to include support for breast cancer, aiming to bridge biomarker testing gaps. This development is part of Tempus’ efforts to integrate patient data with clinical guidelines to improve care. Additionally, Tempus AI revealed plans for a $400 million convertible notes offering, with proceeds intended to repay existing loans and fund general corporate purposes. The company plans to use some of these funds to manage potential stock dilution through capped call transactions. In a strategic move, Tempus AI has also partnered with Northwestern University to advance Alzheimer’s research using its AI-powered data analytics platform. Moreover, TD Cowen has maintained a Buy rating on Tempus AI stock, despite a recent short report that caused a significant stock decline. The analysts believe some concerns in the report were misleading and remain confident in their rating. These recent developments underscore Tempus AI’s ongoing efforts in precision medicine and financial restructuring.
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