HeartSciences shares rise 12.94% premarket after FDA 510(k) submission for MyoVista wavECG device.

HeartSciences surged 12.94% in premarket trading following the announcement that it submitted its MyoVista® wavECG™ device to the U.S. FDA for 510(k) premarket clearance. The submission marks a key regulatory milestone, enabling the company to advance commercialization of the device, which combines conventional ECG functionality with a platform for hosting AI-ECG algorithms. The decision to separate the device and AI algorithm submissions aligns with updated American Society of Echocardiography guidelines, streamlining the regulatory pathway and preserving flexibility for future deployment across its product portfolio. CEO Andrew Simpson emphasized the strategic importance of the filing, noting ongoing progress with its MyoVista Insights platform and active commercial discussions with healthcare institutions. The move underscores confidence in accelerating market access and aligning with evolving clinical standards, driving investor optimism.