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MintNeuro raises 4.4 million euros for chips designed into neural implants iRhythm closes the VitalConnect deal at $287.5M, mostly in cash HeartSciences clears the MyoVista ECG hardware under K260005 without its AI algorithm FDA approves an Abbott update that shows CardioMEMS patients their own pressure readings UK accepts 44 AI commission recommendations and moves to continuous device monitoring Click Therapeutics clears Motivista for the negative symptoms of schizophrenia NeuWire Medical wins an IDE for a 135-patient trial of battery-free vagus nerve stimulation GE HealthCare pays $945M cash for Sofie Biosciences and 15 PET manufacturing sites Zenflow raises $52M and hands Cook Medical US distribution for the Spring implant MintNeuro raises 4.4 million euros for chips designed into neural implants iRhythm closes the VitalConnect deal at $287.5M, mostly in cash HeartSciences clears the MyoVista ECG hardware under K260005 without its AI algorithm FDA approves an Abbott update that shows CardioMEMS patients their own pressure readings UK accepts 44 AI commission recommendations and moves to continuous device monitoring Click Therapeutics clears Motivista for the negative symptoms of schizophrenia NeuWire Medical wins an IDE for a 135-patient trial of battery-free vagus nerve stimulation GE HealthCare pays $945M cash for Sofie Biosciences and 15 PET manufacturing sites Zenflow raises $52M and hands Cook Medical US distribution for the Spring implant

510(k)

HeartSciences clears the MyoVista ECG hardware under K260005 without its AI algorithm

MedDevice Startups Staff · 22 hrs ago · 2 min read · Via HeartSciences (GlobeNewswire)

HeartSciences cleared the MyoVista wavECG under K260005 on October 6. The clearance covers a 12-lead resting electrocardiograph for adult and pediatric patients in hospitals and other healthcare facilities. It provides interpretive statements on an advisory basis and does not include the company's AI-ECG algorithm.

HeartSciences split the hardware and the algorithm into separate submissions after the American Society of Echocardiography updated its guidance on assessing left ventricular diastolic dysfunction. The Southlake, Texas company says it will not commercialize the device without a cleared algorithm and has committed to no timeline. Its commercial focus stays on the MyoVista Insights platform.

Splitting the two was the sensible move once a guideline shifted under the clinical endpoint. The hardware clearance banks a predicate and a device master record, and the algorithm can come back on its own K number without dragging the instrument along with it.

Questions & Answers

What did HeartSciences clear under K260005?

K260005 covers the HeartSciences MyoVista wavECG, a 12-lead resting electrocardiograph for adult and pediatric patients in hospitals and other healthcare facilities. FDA cleared it on October 6, 2026.

Does the MyoVista wavECG clearance include the HeartSciences AI-ECG algorithm?

No. The October 6, 2026 clearance of the MyoVista wavECG under K260005 does not include HeartSciences' AI-ECG algorithm, which remains a separate submission.

Will HeartSciences commercialize the MyoVista wavECG now?

HeartSciences says it does not intend to commercialize the MyoVista wavECG without a cleared AI-ECG algorithm and has set no commercialization timeline. Its commercial focus stays on the MyoVista Insights platform.

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