HeartBeam (Nasdaq:BEAT) announced today that it expanded its product portfolio to add arrhythmia detection capabilities to wearables.
Santa Clara, California-based HeartBeam said in a news release that it aims to serve the growing cardiac device wearable market. The pipeline advancement allows for the addition of arrhythmia detection capabilities for AFib and other arrhythmia monitoring.
The company’s broader product portfolio builds on recently issued patents, HeartBeam said. Its 12-lead electrocardiogram (ECG) patch picked up a patent last month.
HeartBeam introduced a three-lead 3D vector ECG (VECG) credit card-sized HeartBeam AIMIGo 3L device. The device records cardiac activity and displays signals for clinician review. It provides the regulatory foundation for subsequent products in the company’s portfolio. HeartBeam plans to submit to the FDA for 510(k) clearance in the fourth quarter of this year.
Additionally, the company leveraged the recently issued patents to incorporate the 12-lead and synthesized baseline signals for enhanced diagnostic accuracy. It also adds AFib detection capability to the AIMIGo 12L device. HeartBeam plans to submit to the FDA for clearance for that device in the second quarter of 2023.
The company plans to broaden its profile to enable smartwatch connectivity in future products. This would be an optional monitoring solution for the clinician and the patient.
‘A significant development’
“Adding smartwatch connectivity to our platform is a significant development as it extends our portfolio by enabling 24/7 heart monitoring capability,” said Branislav Vajdic, 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.”
HeartBeam said procurement of critical components for the devices for 2023 remains in progress. The company aims to overcome potential supply chain issues, it said.
“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,” said Jon Hunt, 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.”