Tempus AI获FDA 510(k)许可，将肺动脉高压检测加入ECG-AI产品组合

ECG-PH clearance adds pulmonary hypertension to Tempus’
FDA
-cleared AI products for atrial fibrillation and low ejection fraction
CHICAGO
--(BUSINESS WIRE)--Aug. 24, 2026--
Tempus AI, Inc.
(NASDAQ: TEM) today announced it has received 510(k) clearance from the
U.S. Food and Drug Administration
(FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension. Tempus ECG-PH is the third FDA-cleared device in Tempus’ growing cardiovascular portfolio, expanding the company’s suite of next-generation AI products aimed at identifying patients at risk for complex cardiac conditions.
PH is characterized by stiffening and narrowing of the blood vessels in the lungs, putting strain on the right side of the heart. It affects roughly 1% of the population and up to 10% of adults over 65
1
, yet can be difficult to diagnose. PH diagnosis typically requires right heart catheterization, an invasive procedure, and echocardiography.
"Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive,” said
Brandon Fornwalt
, MD, PhD, Senior Vice President of Cardiology at Tempus. “This third FDA-cleared cardiovascular device reflects our broader goal of using AI to help identify patients across the spectrum of cardiovascular disease. We’re building tools that can help clinicians surface risk earlier."
Tempus ECG-PH
Tempus ECG-PH is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with a patient having elevated mean pulmonary artery pressure (mPAP > 20 mmHg), an indicator of pulmonary hypertension (PH). It is for use on clinical diagnostic 12-lead ECG recordings collected at a healthcare facility from patients 40 years of age or older with cardiovascular symptoms (dyspnea, fatigue, chest pain, or edema), who do not have a known history of PH.
Tempus ECG-PH only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-PH is not intended to be a stand-alone diagnostic tool for PH, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should always be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings, as well as the patient’s symptoms, other tests, and clinical history.
About Tempus
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit
tempus.com
.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the expected outcomes and benefits of Tempus ECG-PH and its capabilities for customers. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.
You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2026, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.
1
Hoeper MM, Humbert M, Souza R, et al. A global view of pulmonary hypertension.
The Lancet Respiratory Medicine
2016;4(4):306-322.
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Hanah Heintzelman
hanah.heintzelman@tempus.com
Source:
Tempus AI, Inc.