Heart Test Laboratories Inc. dba HeartSciences, COMP-00066-CAPA-00022, MyoVista Wavelet ECG wavECG

HeartSciences has become aware that when the Frequency Interface filter is active, the filter is not being applied to the Glasgow Program Analysis. This could result in greater than expected variance in test measurements when line-related environmental noise is high and a patient’s lead amplitude is low - i.e., Low Signal-to-Noise ratio (Low SNR). The test measures that could be impacted in this circumstance are measurements from the Glasgow Program Analysis and the overall wavECG Classification.  Whilst most output values remain within tolerance in the presence of Low SNR, the following outputs have been determined to be more sensitive to this condition and may result in larger than expected variance from the actual value.