Heart Test Laboratories has announced that it has submitted its 510(K) application to the Food and Drug Administration (FDA) and a CE Mark certification submission to the British Standards Institute (BSI) group for its MyoVista electrocardiographic device.
FDA clearance is required for Heart Test Labs to market the MyoVista in the United States. CE Mark is the regulatory standard used by the European Union and many other countries around the world.
Based on our device type and current processing times for applications undergoing an expedited review for CE Mark, the company would expect the CE Mark review to be complete in approximately 60 days.
Mark Hilz, CEO for Heart Test Labs, stated, “These two regulatory submissions represent years of diligent effort by our research, development and quality management teams, as well as strong continued support from our shareholders. They represent a key milestone towards commercializing the MyoVista.”
HTL develops medical devices that focus on the early detection of heart disease using proprietary technology. Its first device, the MyoVista assists the physician in the early identification of myocardial dysfunction.
The MyoVista uses standard 12-lead resting ECG protocols to provide a traditional ECG incorporating interpretive analysis, as well as further proprietary informatics to assist a physician in identifying the presence of heart disease.
The MyoVista is ideally suited for use in both primary care and hospital environments. The MyoVista has a 15.6-inch high resolution touchscreen and incorporates user features and functionality commonly associated with a tablet device which make it intuitive and easy to use, thereby reducing training time.
Heart Disease kills 7 million people worldwide each year, more than all cancers combined, and is the largest spend area in healthcare. The MyoVista® helps to address the “diagnostic gap” in heart disease today, which is the identification of patients prior to an adverse cardiac event, such as a heart attack.