News | ECG | July 27, 2023

MyoVista wavECG goes into clinical use at the Naya Imaging Center in Denmark

Abiomed is recalling the Impella Intravascular Left Sided Blood Pumps because the pump’s Instructions for Use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR)

July 27, 2023 — Heart Test Laboratories, Inc. d/b/a HeartSciences, an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announces that its MyoVista wavECG has been selected for commercial use in clinical practice by the Naya Imaging Center in Hvidore, Denmark. 

The Naya Imaging Center is a recently opened private clinic near Copenhagen in Denmark and will provide cardiac testing using the MyoVista as well as imaging and other tests with a focus on preventative screening and diagnostics.  In recent years, HeartSciences has been engaged with a number of physicians in Denmark where the MyoVista is being used in clinical studies at major institutions, including Rigshospitalet Hospital, Bispebjerg Hospital, Frederiksberg Hospital and Holbæk Hospital. 

The MyoVistas in Denmark are prior device versions that are covered by CE mark, rather than the updated version which will be submitted for FDA clearance. The Company intends to update the CE mark under the new EU Medical Device Regulation which is required prior to starting main sales efforts in Europe through distributors. 

Andrew Simpson, CEO of HeartSciences stated, “Heart disease is placing considerable strain on health systems worldwide and is a major health and cost burden. Many international health systems have long waiting lists for cardiac testing and HeartSciences has been working internationally with a number of physicians and key institutions where there is considerable interest in the role that the MyoVista could play in improving cardiac care pathways. It is very encouraging that MyoVista wavECG is starting to be used in clinical practice and bodes well for rapid adoption following the relevant regulatory clearances." 

For more information: https://www.heartsciences.com 

 

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