HeartSciences推出搭载AI心电算法市场及首款FDA获批算法的MyoVista Insights™ 1.3版-动脉网

HeartSciences Launches MyoVista Insights™ Version 1.3 with AI-ECG Algorithm Marketplace and First FDA-Cleared Algorithm

AHHM 等信源发布 2026-06-03 15:35

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HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today announced the commercial release of MyoVista Insights™ version 1.3, a major platform update that introduces the MyoVista Insights AI-ECG Algorithm Marketplace.

专注于通过整合人工智能（AI）推动心电图（ECG或EKG）技术发展的医疗信息技术（HIT）公司HeartSciences Inc.（纳斯达克股票代码：HSCS；HSCSW）（以下简称“HeartSciences”或“公司”）今日宣布，MyoVista Insights™ 1.3版本正式投入商用。此次重大平台更新推出了MyoVista Insights AI-ECG算法市场。

The Marketplace enables third-party algorithm results to be integrated into the MyoVista Insights platform, beginning with an FDA-cleared AI-ECG model from Bunkerhill Health. The Bunkerhill ECG-EF model enables clinicians to detect reduced left ventricular ejection fraction (LVEF ≤40%) from a routine 12-lead ECG..

该平台市场支持将第三方算法结果集成至MyoVista Insights平台，首期接入的是Bunkerhill Health公司一款已获FDA批准的人工智能心电图（AI-ECG）模型。Bunkerhill ECG-EF模型可帮助临床医生通过常规12导联心电图检测左心室射血分数降低（LVEF ≤40%）的情况。

The launch marks the first time a cleared AI-ECG algorithm is available through MyoVista Insights, making the ECG-EF algorithm accessible to healthcare facilities of every size, from large integrated health systems to community hospitals, critical access hospitals, and primary care practices across the United States.

此次发布标志着首款获批的AI-ECG算法首次通过MyoVista Insights平台提供，使ECG-EF算法得以惠及全美各类规模的医疗机构，从大型整合型医疗系统、社区医院、关键接入医院到初级保健诊所。

It also establishes the platform as a commercial pathway for AI-ECG developers seeking to reach clinical users through a recurring, SaaS-based revenue model, without the cost or complexity, of building their own end-to-end workflow and distribution infrastructure. HeartSciences is in active discussions to add further third-party owned and cleared algorithms and expects the marketplace to expand over the coming quarters..

该平台还确立了其作为AI-ECG开发者商业渠道的地位，使开发者能够通过基于SaaS的经常性收入模式触达临床用户，而无需承担自建端到端工作流程与分发基础设施的成本和复杂性。HeartSciences目前正积极洽谈，计划引入更多第三方持有且已获批的算法，并预计该市场将在未来几个季度持续扩展。

Andrew Simpson, Chief Executive Officer of HeartSciences, said, “The launch of our AI-ECG marketplace is a defining milestone for HeartSciences. We are now delivering a cleared AI-ECG algorithm into clinical workflows through MyoVista Insights, with a recurring, SaaS-based revenue model that we believe can create meaningful and scalable value for the Company.

HeartSciences首席执行官安德鲁·辛普森表示：“我们AI心电图市场的推出是HeartSciences的一个标志性里程碑。目前，我们正通过MyoVista Insights平台，将已获批准的AI心电图算法融入临床工作流程中。依托基于SaaS的经常性收入模式，我们相信这将为公司创造显著且可扩展的价值。”

Bunkerhill’s ECG-EF algorithm is the first of what we expect to be many. We are in active discussions with additional algorithm developers who recognize that delivering algorithms into clinical practice, not simply developing them, is the critical step, and we believe MyoVista Insights is uniquely positioned to be that delivery platform for institutions of every size.”.

Bunkerhill的ECG-EF算法仅是我们预期将推出的众多算法中的首个。我们正与其他算法开发者积极洽谈，他们同样认识到，将算法真正应用于临床实践，而非仅仅停留在开发阶段，才是关键所在。我们相信，MyoVista Insights 独具优势，完全能够成为服务于各类规模医疗机构的算法交付平台。

Detection of reduced LVEF from a routine ECG supports earlier identification and is expected to result in more effective referral of patients at risk of heart failure. Assessments performed with assistive AI-ECG algorithms are eligible for Medicare reimbursement under the Hospital Outpatient Prospective Payment System, assigned to Ambulatory Payment Classification (APC) 5734 at a national payment rate of approximately $136 per assessment for 2026.

通过常规心电图检测出左心室射血分数（LVEF）降低有助于早期识别，并有望更有效地转诊有心衰风险的患者。采用辅助AI心电图算法进行的评估符合联邦医疗保险（Medicare）的报销条件，该报销纳入医院门诊前瞻性支付系统，并被归入门诊支付分类（APC）5734，2026年的全国统一支付标准约为每次评估136美元。

With AI-ECG forecast to become a multi-billion-dollar market, HeartSciences believes an established reimbursement pathway, combined with its recurring SaaS-based revenue model, positions the Company to capture meaningful and scalable revenue as adoption grows and additional algorithms are added to the platform..

鉴于AI-ECG预计将成为数十亿美元规模的市场，HeartSciences认为，凭借已建立的报销渠道与基于SaaS的经常性收入模式相结合，随着应用普及率的提升及平台不断引入更多算法，公司将有望获取可观且可规模化的收入。

Nishith Khandwala, Co-founder and Chief Executive Officer of Bunkerhill Health, added, “We share HeartSciences’ commitment to making advanced cardiac AI more accessible in everyday clinical practice. This collaboration gives more health systems a pathway to adopt our FDA-cleared ECG-EF algorithm and to use routine ECG data to support earlier evaluation and more informed clinical decisions for patients at risk of heart failure.”.

Bunkerhill Health 联合创始人兼首席执行官 Nishith Khandwala 补充道：“我们与 HeartSciences 秉持相同的承诺，致力于让先进的心脏人工智能在日常临床实践中更加普及。此次合作为更多医疗机构提供了一条采用我们获 FDA 批准的 ECG-EF 算法的途径，从而利用常规心电图数据，为有心衰风险的患者提供早期评估支持，并辅助制定更具依据的临床决策。”

MyoVista Insights is a cloud-native, next-generation ECG management system designed to be device-agnostic that delivers workflow efficiency and third-party, FDA-cleared AI results directly into clinical practice. Because it is cloud-based, cost-effective, and independent of any single manufacturer’s hardware, the platform gives institutions of every size a unified environment for deploying cleared AI-ECG algorithms within routine clinical workflows.

MyoVista Insights 是一款云原生、新一代心电图（ECG）管理系统，采用不依赖特定设备的设计，旨在将高效的工作流程与第三方获FDA批准的AI分析结果直接应用于临床实践。凭借云端架构、高性价比以及不绑定单一厂商硬件的特性，该平台为各类规模的医疗机构提供了统一的环境，便于在常规临床工作流程中部署已获批准的AI心电图算法。

MyoVista Insights holds Epic Toolbox designation for the ECG Management System category and supports integration with electronic health records through HL7v2 order and results workflows, single sign-on (SSO), and SMART on FHIR..

MyoVista Insights 已获心电图管理系统类别的 Epic Toolbox 认证，并支持通过 HL7v2 医嘱与结果工作流、单点登录（SSO）以及 SMART on FHIR 与电子健康记录系统集成。

About HeartSciences

关于 HeartSciences

HeartSciences is a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”). The Company’s MyoVista Insights platform is a device-agnostic, next-generation ECG management system designed to improve clinical efficiency and decision-making.

HeartSciences 是一家医疗信息技术（“HIT”）公司，致力于通过整合人工智能（“AI”）技术来推动心电图（ECG/EKG）的应用。该公司的 MyoVista Insights 平台是一款设备无关的新一代心电图管理系统，旨在提升临床效率并优化临床决策。

Its MyoVista wavECG device is designed to deliver conventional ECG functionality while supporting on-device AI-enabled solutions..

其 MyoVista wavECG 设备旨在提供常规心电图功能，同时支持设备端人工智能解决方案。

For more information, please visit: https://www.heartsciences.com. X: @HeartSciences

欲了解更多信息，请访问：https://www.heartsciences.com。X：@HeartSciences

About Bunkerhill Health

关于 Bunkerhill Health

Bunkerhill Health delivers generative AI for clinical reasoning and action. Its flagship platform, Carebricks, analyzes structured and unstructured patient data to understand each patient’s full history, apply AI-powered reasoning across all available context, and automate next steps. Carebricks helps health systems improve outcomes, increase efficiency, and close care gaps without adding to clinician workload..

Bunkerhill Health 提供面向临床推理与干预的生成式人工智能。其旗舰平台 Carebricks 通过分析结构化和非结构化患者数据，全面掌握每位患者的完整病史，基于所有可用上下文进行 AI 驱动的推理，并自动执行后续步骤。Carebricks 帮助医疗机构改善治疗效果、提升效率并弥补诊疗缺口，且不会增加临床医生的工作负担。

For more information, please visit https://www.bunkerhillhealth.com/.

如需更多信息，请访问 https://www.bunkerhillhealth.com/。

Safe Harbor Statement

安全港声明

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance.

本公告包含经修订的《1933年证券法》第27A条及经修订的《1934年证券交易法》第21E条所指的前瞻性陈述。该等前瞻性陈述系根据《1995年私人证券诉讼改革法》的“安全港”条款作出，涉及公司未来的财务及经营业绩。

All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control.

除历史事实陈述外，本文包含的所有陈述均为“前瞻性陈述”，其中包括（但不限于）关于HeartSciences信念与期望的陈述。该等陈述基于当前的预期、假设与不确定性，涉及对（其中包括）未来经济、竞争及市场状况以及未来商业决策的判断。所有这些因素均难以或无法准确预测，且其中许多因素超出公司的控制范围。

The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

这些前瞻性陈述所反映的预期涉及重大假设、风险和不确定性，该等预期可能被证明是不正确的。投资者不应过度依赖这些前瞻性陈述，其仅反映本新闻稿发布之日的情况。

Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 24, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2025 filed with the SEC on September 11, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2025 filed with the SEC on December 15, 2025, HeartSciences’ Quarterly Report on Form 10-Q .

潜在风险和不确定性包括但不限于HeartSciences截至2025年4月30日财政年度的10-K表格年度报告（于2025年7月24日提交至美国证券交易委员会（“SEC”））中所述风险、截至2025年7月31日财政季度的10-Q表格季度报告（于2025年9月11日提交至SEC）中所述风险、截至2025年10月31日财政季度的10-Q表格季度报告（于2025年12月15日提交至SEC）中所述风险，以及HeartSciences的10-Q表格季度报告中所述风险。

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