乐普医疗(300003.SZ)人工智能心电图机获得NMPA注册申请受理
格隆汇6月6日丨乐普医疗(300003.SZ)公布,公司今日获悉,公司全资子公司深圳市凯沃尔电子有限公司自主研制的人工智能心电图机(OmniECG B120 AI)于2019年6月6日获得国家药品监督管理局下发的《受理通知书》。该产品是公司推出的国内首款新一代心电图自动分析诊断研发和产业化的专业医用级人工智能心电图自动分析设备。
心电图是心血管疾病最简单、快捷、经济的临床检查方法,是心血管疾病检验的基石。人工智能心电图机(OmniECG B120 AI)分析诊断算法是基于已提交NMPA注册的心电人工智能分析软件(AI-ECG Platform)的嵌入式AI模块心电图自动分析产品,通过12导联同步采集心电信号,并对心电信号进行显示、分析和记录,可诊断分析心律失常、心肌梗死、心室肥大和ST-T异常改变等心血管疾病。数据对比显示,该设备正常心电图诊断准确率99%以上,心律失常及心脏激动传导异常分析诊断准确率95%以上。
该产品获批后,将快速实现在国内医院、个体诊所、体检中心、社康中心、养老机构等医疗机构进行商业化推广应用,既解决了国内大量缺乏专业心电医生的问题,又解放了大型医院专业心电医生的劳动力,切实提高工作效率,提升诊断水平,形成一体化的人工智能心电分析诊断技术服务链,实现患者在这些医疗机构的属地化、快速化心电分析和诊断,满足相关医疗服务的刚性需求,切实造福国内广大的心血管疾病患者。
公司人工智能心电图机(OmniECG B120 AI)注册申请受理后,须经国家药品监督管理局审批,鉴于注册审批的周期性及不确定性。
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