HeartSciences, a medical device company focused on advancing the field of electrocardiology through innovation, announced submission to the U.S. FDA via De Novo premarket review pathway for the MyoVista Wavelet ECG (wavECG) Cardiac Testing Device. The De Novo pathway is used for novel medical devices that are low to moderate risk.
“HeartSciences seeks to bridge today’s “diagnostic gap” in cardiac care through innovation in front-line ECG solutions that assist in the detection of heart disease in at-risk patients. Abnormal left ventricular relaxation is typically the earliest manifestation of diastolic dysfunction,” said Mark Hilz, HeartSciences’ CEO. “LV diastolic function is also now well understood to be impaired by all of the common heart disease processes that affect LV function. Thus, detecting impaired relaxation through the use of 12-lead ECG testing can be a game-changer for front-line heart disease testing.”
“This is an important milestone and the result of years of research and development focused on advancing the field of electrocardiography. Through the use of advanced technology, it is now possible to develop new algorithms focused on detecting cardiac states related to heart disease not previously detected by conventional ECG devices.” said Andrew Simpson, HeartSciences’ Executive Chairman.
South Lake, Texas-based HeartSciences’ request for De Novo classification is supported by clinical data collected in prospective, non-randomized, clinical studies conducted at three institutions which were aggregated into an overall clinical study dataset. The subject data (n=395 Validation Dataset) used to validate the performance of the wavECG Algorithm was not used in any aspect of the development of the wavECG Algorithms.