The 510k clearance has significant limitations that are not reflected in the article.
"The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any
recommendation toward a clinical diagnosis and is not intended to be used with automated ECG
analysis systems. "
"It reports a series of 3-lead ECG rhythm strips for manual interpretation. "
"Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate
certain types of arrhythmias"
"The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or
other morphological ECG evaluation."
Without the ability to analyze T-waves, there is no way to analyze myocardial infarctions which is the thesis of the company.
Thanks for the comment. My understanding is that the system is part one of a multi step process. They need to get the next approval of the software to allow for some of these items you have listed. The long term goal is infarctions but they should be able to handle rhythms and arrhythmias, including sinus rhythm, atrial fibrillation, atrial flutter, bradycardia, tachycardia, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC).
The 510k clearance has significant limitations that are not reflected in the article.
"The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any
recommendation toward a clinical diagnosis and is not intended to be used with automated ECG
analysis systems. "
"It reports a series of 3-lead ECG rhythm strips for manual interpretation. "
"Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate
certain types of arrhythmias"
"The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or
other morphological ECG evaluation."
Without the ability to analyze T-waves, there is no way to analyze myocardial infarctions which is the thesis of the company.
Thanks for the comment. My understanding is that the system is part one of a multi step process. They need to get the next approval of the software to allow for some of these items you have listed. The long term goal is infarctions but they should be able to handle rhythms and arrhythmias, including sinus rhythm, atrial fibrillation, atrial flutter, bradycardia, tachycardia, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC).
I am an amateur when it comes to healthcare investing. But to me, this was pretty compelling. Thanks for the great work on this write-up!