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-MR, an AI product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR)..

Tempus AI, Inc.（纳斯达克股票代码：TEM）今日宣布，其人工智能产品 Tempus ECG-MR 已获得美国食品药品监督管理局（FDA）的 510(k) 许可。该产品通过分析标准的 12 导联静息心电图（ECG），检测与未确诊的中度或重度二尖瓣反流（MR）相关的迹象。

MR is a common form of heart valve disease where blood leaks backward through the mitral valve. Because early stages are often asymptomatic or manifest as non-specific symptoms like shortness of breath, MR frequently remains undiagnosed until advanced stages. Tempus ECG-MR serves as an early detection tool to help identify high-risk patients who should be referred for further evaluation, such as follow-up diagnostic imaging..

二尖瓣反流（MR）是一种常见的心脏瓣膜病，其特征是血液通过二尖瓣向后渗漏。由于早期阶段通常无症状，或仅表现为气短等非特异性症状，MR 往往在进展至晚期时才被诊断。Tempus ECG-MR 作为一种早期检测工具，有助于识别应转诊进行进一步评估（如后续诊断性影像学检查）的高风险患者。

“A standard ECG contains far more information than we have traditionally been able to use,” said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. 'With the fourth FDA-cleared Tempus ECG-AI product, we’re building a growing portfolio that can identify signals across numerous types of heart and vascular disease from the same ECG, helping provide clinicians with more actionable information from a test already embedded in everyday care.'.

“标准心电图包含的信息远多于我们传统上能够利用的信息，”Tempus心血管病学高级副总裁Brandon Fornwalt医学博士、哲学博士表示。“随着第四款获得美国食品药品监督管理局（FDA）许可的Tempus ECG-AI产品问世，我们正在构建一个日益丰富的产品组合，能够从同一份心电图中识别多种心脏和血管疾病的信号，从而帮助临床医生从这项已融入日常诊疗的检查中获取更具可操作性的信息。”

Tempus ECG-MR

Tempus 心电图-磁共振

Tempus ECG-MR is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having moderate or severe mitral regurgitation (MR). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 65 years of age or older at risk of cardiovascular disease.

Tempus ECG-MR 是一款软件，旨在分析静息、非动态的12导联心电图记录，并检测与中度或重度二尖瓣反流（MR）相关的征象。该软件适用于在医疗机构收集的、患有心血管疾病风险的65岁及以上患者的临床诊断用心电图记录。

Such cardiovascular risk factors include, but are not limited to, history of coronary artery disease, hypertension, obesity, or diabetes; or other signs or symptoms of heart disease, such as dyspnea, chest pain, or lower extremity edema. The device is indicated for patients without prior mitral valve intervention and without prior diagnosis of moderate or severe mitral regurgitation..

此类心血管风险因素包括但不限于冠心病史、高血压、肥胖或糖尿病；或其他心脏病体征或症状，如呼吸困难、胸痛或下肢水肿。该器械适用于既往未接受过二尖瓣干预且既往未诊断为中度或重度二尖瓣反流的患者。

Tempus ECG-MR only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-MR is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history..

Tempus ECG-MR 仅分析心电图数据，并提供用于解读的二元输出结果。Tempus ECG-MR 并非旨在作为心脏疾病诊断的独立工具，不应用于患者的连续监测，也不应用于带有起搏节律的心电图。其结果应结合其他诊断信息进行解读，包括患者的原始心电图记录和其他检查结果，以及患者的症状和临床病史。

About Tempus

关于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.

Tempus 是一家科技公司，通过在医疗领域实际应用人工智能来推动精准医学的发展。凭借全球最大的多模态数据图书馆之一，以及一个使这些数据易于访问和使用的操作系统，Tempus 为医生提供基于人工智能的精准医学解决方案，以实现个性化的患者护理，同时促进最佳治疗方法的发现、开发和交付。

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..

我们的目标是，随着公司积累更多数据，为医生提供能够不断学习的工具，从而使每位患者都能从既往患者的治疗中获益。如需更多信息，请访问 tempus.com。

Forward Looking Statements

前瞻性陈述

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.

本新闻稿包含根据经修订的《1933年证券法》（以下简称“《证券法》”）第27A条和经修订的《1934年证券交易法》第21E条所定义的关于Tempus及其所在行业的前瞻性陈述，这些陈述涉及重大风险和不确定性。

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-MR 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.

本新闻稿中包含的所有非历史事实陈述均为前瞻性陈述，包括但不限于有关Tempus ECG-MR的预期结果和益处及其为客户提供的能力的陈述。在某些情况下，您可以通过其中包含诸如“预期”、“相信”、“考虑”、“继续”、“可能”、“估计”、“期望”、“将会”、“打算”、“可以”、“计划”、“潜在”、“预测”、“规划”、“应该”、“目标”、“将”或“会”等词语，或这些词语的否定形式或其他类似术语或表达来识别前瞻性陈述。

Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release..

Tempus 提醒您，上述内容可能并未涵盖本新闻稿中作出的所有前瞻性陈述。

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.

您不应将前瞻性陈述视为对未来事件的预测。Tempus 在本新闻稿中包含的前瞻性陈述主要基于其目前对未来事件和趋势的预期与预测，公司认为这些事件和趋势可能会影响 Tempus 的业务、财务状况、经营成果及前景。

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.

这些前瞻性陈述受限于与以下方面相关的风险和不确定性：Tempus的财务表现；吸引和保留客户及合作伙伴的能力；管理Tempus的增长及未来费用；竞争及新市场进入者；遵守新法律、法规及行政行动，包括人工智能领域不断演变的任何法规；维持、保护和增强Tempus知识产权的能力；吸引和保留合格团队成员及关键人员的能力；偿还或再融资未偿债务或获得额外融资的能力；未来的收购、剥离或投资；气候变化、自然灾害、健康流行病、宏观经济状况以及战争或其他武装冲突的潜在不利影响；以及Tempus于2026年2月24日向美国证券交易委员会（“SEC”）提交的截至2025年12月31日止年度的Form 10-K年度报告中“风险因素”一节所述的风险、不确定性和其他因素，以及Tempus未来可能向SEC提交的其他文件中所述的风险、不确定性和其他因素。

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.

此外，本新闻稿中包含的任何前瞻性陈述均基于Tempus认为截至本日合理的假设。Tempus不承担更新任何前瞻性陈述以反映本新闻稿发布日期之后发生的事件或情况的义务。

Contacts

联系人

Kelli Manalli

凯莉·马纳利

312-402-5060

312-402-5060

Source: businesswire.com

来源：businesswire.com