心脏Beam在家中的12个领先ECG装置 获得FDA批准 进行远程心律失常检测 HeartBeam's cable-free, at-home 12-lead ECG device received FDA approval for remote arrhythmia detection.

HeartBeam公司获得了FDA 510(k)许可,用于其家用12级领先ECG无线合成软件,这是美国批准用于远程心律失常评估的首个此类装置。 HeartBeam, Inc. received FDA 510(k) clearance for its cable-free, at-home 12-lead ECG synthesis software, the first such device approved in the U.S. for remote arrhythmia assessment. 信用卡大小装置捕捉3D心脏信号,将其合成成完整的ECG,由心脏病学家审查。 The credit-card-sized device captures 3D heart signals and synthesizes them into a full ECG, which is reviewed by cardiologists. 批准是在对早先的否决成功上诉之后作出的,并有诊断准确度高的数据作为佐证。 The approval follows a successful appeal of an earlier rejection and is backed by data showing high diagnostic accuracy. 该公司计划在2026年初进行一次有限度的美国发射,目标是预防性心脏病学做法,未来目标包括心脏病发作检测、长袖和AI动力筛查工具。 The company plans a limited U.S. launch in early 2026, targeting preventive cardiology practices, with future goals including heart attack detection, an extended-wear patch, and AI-powered screening tools.