AIMIGo, a personal, portable vector electrocardiogram (VECG) system assists patients and clinicians in assessing cardiac symptoms. It utilizes a reusable, credit card-sized VECG recording device and cloud-based software. The system can deliver critical data to clinicians in real-time outside of a medical setting.
HeartBeam’s 12-lead 3D vector electrocardiogram (ECG) device pairs with a smartphone app and cloud-based diagnostic software system. It can facilitate remote heart attack detection.
“The 510(k) submission of our HeartBeam AIMIGo VECG device is an important milestone for the company,” said Branislav Vajdic, HeartBeam CEO and founder. “We believe that our patented VECG technology holds tremendous promise to provide timely and actionable information to patients and their clinicians. This submission is the result of years of hard work to develop and refine the technology. I am extremely proud of our team and all their efforts to get the product to this stage. We look forward to working with the FDA as they review this application.
Earlier this month, HeartBeam announced that it raised $23.2 million. The company said it expects the funds to support its upcoming clinical and regulatory milestones related to AIMIGo. HeartBeam aims to commercialize AIMIGo in 2024.
“This year is pivotal for HeartBeam. In addition to this FDA submission, we are undertaking clinical studies on the system’s ability to synthesize a 12-lead ECG from our VECG signal, providing clinicians with the output that they expect in evaluating cardiac patients. Our recently announced $26.5 million capital raise will allow us to accelerate our clinical studies and activities related to our FDA submissions,” added Vajdic.