The US Food and Drug Administration (FDA) has granted 510(k) clearance for Tempus AI’s ECG-Low (ejection fraction) EF software.

美国食品药品监督管理局 (FDA) 已授予 Tempus AI 的 ECG-Low（射血分数）EF 软件 510(k) 许可。

This software utilises AI to detect individuals with a low left ventricular ejection fraction (LVEF).

该软件利用人工智能检测左心室射血分数 (LVEF) 较低的个体。

It is the latest addition to the company’s suite of ECG-AI devices, designed to detect at-risk patients of various cardiovascular conditions.

它是该公司最新推出的ECG-AI设备系列的一部分，旨在检测各种心血管疾病的高风险患者。

Tempus’ ECG-AI solutions are said to work with current ECG platforms and electronic health records (EHRs), integrating AI insights directly into clinical workflows.

Tempus的ECG-AI解决方案据说可与当前的ECG平台和电子健康记录（EHR）配合使用，将AI洞察直接整合到临床工作流程中。

The EF model is trained on data from over 930,000 ECGs and more than 170,000 individuals.

EF 模型训练了来自超过 930,000 份心电图和 170,000 多名个体的数据。

The company noted that for those who obtain a positive outcome from Tempus’ ECG-Low EF test, the LVEF of 40% or lower will be identified in nearly two in five subjects when assessed by echocardiogram.

该公司指出，对于那些从 Tempus 的 ECG-Low EF 测试中获得阳性结果的人群，在通过超声心动图评估时，几乎每五人中有两人会发现其 LVEF 值为 40% 或更低。

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美国关税正在变化——你会做出反应还是提前预料？

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不要让政策变化让你措手不及。通过实时数据和专家分析保持主动性。

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A minimised LVEF potentially indicates cardiomyopathy, heart failure, or damage from a previous heart attack.

左心室射血分数（LVEF）的降低可能表明心肌病、心力衰竭或之前心脏病发作造成的损伤。

The software is designed for analysing resting, non-ambulatory 12-lead ECG recordings in a clinical setting.

该软件旨在临床环境中分析静息、非移动的12导联心电图记录。

It is intended for those who are aged 40 years or above with heart failure risk, including those with conditions such as aortic stenosis, atrial fibrillation, and diabetes.

它适用于40岁及以上有心力衰竭风险的人群，包括那些患有主动脉瓣狭窄、心房颤动和糖尿病等疾病的人。

Tempus noted that the software offers a binary output for interpretation and is not designed to function as an independent diagnostic instrument for cardiac conditions.

Tempus 指出，该软件提供用于解释的二进制输出，并非设计用于作为心脏状况的独立诊断工具。

Additionally, it should not be used for monitoring of patients or on ECGs with paced rhythms.

此外，它不应用于患者监护，也不应用于带有起搏心律的ECG。

Outcomes from the Tempus ECG-Low EF should be considered alongside other diagnostic information for a comprehensive clinical evaluation.

Tempus ECG-Low EF 的结果应与其他诊断信息结合考虑，以进行全面的临床评估。

Tempus cardiology senior vice-president Brandon Fornwalt said: “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.

Tempus心脏病学高级副总裁布兰登·福尔诺瓦特表示：“通过Tempus ECG-Low EF，我们为临床医生提供了另一个强大的工具，帮助他们在患者护理旅程的更早阶段识别出患有严重心血管疾病风险的患者。

“Detection of LVEF is essential for undiagnosed patients, and this technology enables us to deliver that capability at scale to transform patient care. The addition of a second FDA-cleared Tempus ECG-AI solution reflects our continued commitment to advancing AI-driven cardiology.”

“对于未确诊的患者来说，检测LVEF是至关重要的，而这项技术使我们能够大规模提供这种能力，从而改变患者的护理。第二个获得FDA批准的Tempus ECG-AI解决方案的加入，体现了我们持续推进AI驱动的心脏病学的承诺。”

In May 2025, Tempus AI

2025年5月，Tempus AI

announced the expansion of its collaboration

宣布扩大其合作

with Verastem Oncology to develop a companion diagnostic for the latter’s KRAS-mutant recurrent low-grade serous ovarian cancer (LGSOC) combination treatment.

与Verastem肿瘤学合作，为其KRAS突变复发性低级别浆液性卵巢癌（LGSOC）联合治疗开发伴随诊断。