HeartBeam的ECG技术在心律失常诊断研究中显示出潜力-动脉网

HeartBeam’s ECG technology shows promise in study for arrhythmia diagnosis

Medical Device Network 等信源发布 2025-05-01 10:18



可切换为仅中文







The company’s 3D ECG technology captures the electrical signals of the heart from three non-coplanar directions. Credit: Natali _ Mis / Shutterstock.

该公司的心电图 3D 技术可从三个非共面方向采集心脏的电信号。 кредит: Natali _ Mis / Shutterstock。

HeartBeam’s synthesised 12-lead electrocardiogram (ECG) has met the clinical endpoints in the VALID-ECG pivotal study, assessing non-life-threatening arrhythmias.

HeartBeam的合成12导联心电图（ECG）在VALID-ECG关键研究中达到了临床终点，该研究评估非危及生命的 arrhythmias。

In the study, the mean difference in ECG intervals and amplitude between the company’s ECG and the standard 12-lead ECG was assessed.

在研究中，评估了该公司心电图与标准12导联心电图之间的心电图间期和振幅的平均差异。

Go deeper with GlobalData

深入挖掘全球数据

Reports

报告

Internet of Things in Medical Devices: Remote EEG/ECG Monitoring

医疗设备中的物联网：远程脑电图/心电图监测

Reports

报告

Electrophysiology Ablation Catheters Market Size (Value, Volume, AS...

电生理消融导管市场规模（价值、数量、AS...

Data Insights

数据洞察

The gold standard of business intelligence.

商业智能的黄金标准。

Find out more

了解更多

Findings highlight a 93.4% diagnostic agreement, suggesting that HeartBeam’s system is comparable to traditional 12-lead ECGs in diagnosing arrhythmias.

研究结果显示，诊断一致性高达93.4%，表明HeartBeam的系统在心律失常诊断方面与传统的12导联心电图相当。

The multicentre study enrolled 198 subjects across five US clinical sites, including Mount Sinai Hospital, Atlanta Heart Specialists, Allegheny Health Network, Piedmont Heart Institute, and Northwell Health.

这项多中心研究在美国五个临床地点共招募了198名受试者，包括西奈山医院、亚特兰大心脏专科、阿勒格尼健康网络、皮埃蒙特心脏研究所和北岸医疗集团。

HeartBeam CEO Robert Eno said: “This important milestone successfully confirms that our novel technology can deliver diagnostic insights similar to a standard 12-lead ECGs for arrhythmia assessment.

HeartBeam首席执行官罗伯特·恩诺表示：“这一重要里程碑成功证实，我们的创新技术可以提供与标准12导联心电图相似的诊断见解，用于心律失常评估。

“The ability to deliver 12-lead ECG-like data through a credit card-sized device that patients can use whenever and wherever arrhythmia symptoms occur underscores our long-term vision of bringing advanced cardiac health insights beyond medical facilities to improve patient outcomes.”

“通过一个信用卡大小的设备，在患者出现心律失常症状时随时随地提供类似12导联心电图的数据，这一能力突显了我们将先进的心脏健康洞察从医疗机构扩展到日常生活的长期愿景，以改善患者的治疗效果。”

GlobalData Strategic Intelligence

全球数据战略情报

US Tariffs are shifting - will you react or anticipate?

美国关税正在变化——你会做出反应还是提前预料？

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

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。

By GlobalData

由GlobalData提供

Learn more about Strategic Intelligence

了解有关战略情报的更多信息

In January 2025, HeartBeam rolled out an application for its 12-lead ECG synthesis software to the US Food and Drug Administration (FDA), based on the data from this study.

2025年1月，HeartBeam基于本研究的数据，向美国食品和药物管理局 (FDA) 提交了其12导联心电图合成软件的申请。

In anticipation of FDA clearance, the company has initiated an early access programme to gather feedback on clinical workflows and prepare for US commercialisation.

公司预计不久将获得FDA的批准，现已启动了一个抢先体验计划，以收集有关临床工作流程的反馈，并为美国商业化做好准备。

The company noted that its patented three-dimensional ECG technology captures the electrical signals of the heart from three non-coplanar directions.

该公司指出，其获得专利的三维心电图技术可从三个非共面方向采集心脏的电信号。

These signals are then synthesised into a 12-lead ECG using a transformation matrix.

这些信号随后使用变换矩阵合成为12导联心电图。

HeartBeam’s platform technology is tailored for portable devices used by individuals anywhere to deliver actionable heart intelligence.

HeartBeam的平台技术专为个人在任何地方使用的便携式设备量身定制，以提供可操作的心脏智能。

Healthcare providers can guide their patients to the appropriate care outside of medical facilities by detecting acute heart conditions and health trends.

通过检测急性心脏状况和健康趋势，医疗保健提供者可以引导患者在医疗机构外获得适当的护理。

HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December last year.

HeartBeam的3D ECG技术于去年12月获得FDA批准，用于心律失常评估。

Last week, HeartBeam partnered with AccurKardia to enhance

上周，HeartBeam与AccurKardia合作以增强

cardiac monitoring solutions’ accessibility

心脏监测解决方案的可及性

。

注册获取我们的每日新闻汇总！

Give your business an edge with our leading industry insights.

通过我们领先的行业洞察，为您的企业带来优势。

Copy Link