Cardiac technology company HeartBeam developed a 3D-vector ECG platform for remote heart attack detection and announced the expansion of its product portfolio pipeline to serve the growing cardiac device wearable technology market by bringing clinically relevant diagnostic information to patients and clinicians.
The product pipeline advancement allows for the addition of arrhythmia detection capabilities to address the multibillion-dollar global market for atrial fibrillation and other arrhythmia monitoring.
Building on HeartBeam’s recently issued patents, the broader product portfolio enables the following:
- Introducing a 3-lead 3D vector electrocardiogram (VECG) credit card-sized device, the HeartBeam AIMIGo 3L, that records the X,Y,Z cardiac activity and displays the signals for clinician review, providing the regulatory foundation for subsequent products in HeartBeam’s product portfolio. The 510(K) submission to the United States Food and Drug Administration (FDA) is planned for Q4 2022.
- Leveraging recently issued patents to incorporate both synthesized baseline and symptomatic 12-lead signals for enhanced diagnostic accuracy as well as the addition of atrial fibrillation detection capability in the AIMIGo 12L device for FDA 510(K) submission in Q2 2023.
- Broadening of the product portfolio profile to enable smartwatch connectivity to HeartBeam’s platform in future products as an optional monitoring solution for the clinician and the patient.
“Adding smartwatch connectivity to our platform is a significant development as it extends our portfolio by enabling 24/7 heart monitoring capability,” says Branislav Vajdic, PhD, HeartBeam Founder and CEO. “Coupled with our breakthrough AIMIGo solution, we believe the overall HeartBeam system will bring a new and much higher level of diagnostic capability to cardiac patients. We continue to make steady progress in realizing our vision of bringing comprehensive cardiac care to patients anytime, anywhere.”
To overcome potential supply chain issues, procurement of critical components for the company’s planned AIMIGo device production quantities for 2023 are in progress.
“We are pleased to announce that our novel AIMIGo heart attack solution will be significantly enhanced by the addition of automated atrial fibrillation detection and smartwatch connectivity,” says Jon Hunt, PhD, HeartBeam chief business officer. “This is an immense step forward for our powerful AIMIGo platform as it adds a significant and established market for detection of atrial arrhythmias.”