HeartSciences近日获得美国食品药品监督管理局（FDA）的510(k) clearance，用于其MyoVista® wavECG设备。
HeartSciences Inc. 获得了其 MyoVista® wavECG 设备的 FDA 510(k) 许可，允许该设备在医院和医疗机构中用于 12 导联静息心电图。该许可不包括 AI-ECG 算法，公司计划评估其商业化选项。
为什么重要. HeartSciences的设备现在可以在临床环境中使用，这可能有助于改善心电图工作流程和临床决策。
01
证据
- GGlobeNewswire public company news公司披露2026-10-06 20:30
the recoverability of the related inventory
- GGlobeNewswire public company news公司披露2026-10-06 20:30
HeartSciences’ amended preliminary proxy statement on Schedule 14A, filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 6, 2026, in connection with the Proposed Transaction (the “Preliminary Proxy Statement”)
- GGlobeNewswire public company news公司披露2026-10-06 20:30
HeartSciences is a healthcare information technology company advancing the use of ECG/EKGs through the integration of artificial intelligence.
- GGlobeNewswire public company news公司披露2026-10-06 20:30
HeartSciences’ MyoVista Insights™ Platform is a cloud-native, vendor- and device-agnostic ECG management system designed to modernize ECG workflows and improve clinical efficiency and decision-making.
- GGlobeNewswire public company news公司披露2026-10-06 20:30
The proposed business combination with Fortitude Mining Holdings, Inc. (“Fortitude”), announced in June 2026 (the “Proposed Transaction”), continues to progress.
- GGlobeNewswire public company news公司披露2026-10-06 20:30
As previously reported, HeartSciences separated the FDA submissions for the MyoVista wavECG device and its impaired cardiac relaxation AI-ECG algorithm following updated guidance published by the American Society of Echocardiography regarding the assessment of left ventricular d…
- GGlobeNewswire public company news公司披露2026-10-06 20:30
Food and Drug Administration (“FDA”) has granted 510(k) clearance (K260005) for its MyoVista® wavECGTM device as a 12-lead resting electrocardiograph. The clearance covers the acquisition and interpretation of ECG signals from adult and pediatric patients in hospitals and health…