HeartBeam, Inc. (NASDAQ: BEAT), a groundbreaking cardiac technology company, has taken an incredible step forward in the medical industry today with the submission of a 510(k) application to the U.S. Food and Drug Administration (FDA) for its HeartBeam AIMIGo™ System. This revolutionary 3D vector electrocardiogram (VECG) platform is designed for patient use in the comfort of their own homes, making this a truly revolutionary medical advancement.
HeartBeam has revolutionized cardiac care with the introduction of the HeartBeam AIMIGo System, a personal, portable, and easy-to-use VECG solution. This revolutionary technology utilizes a reusable, credit card-sized VECG recording device and cloud-based software to deliver critical data to clinicians in real-time outside of a medical setting.
With over 127 million people in the US suffering from cardiovascular disease, including 20 million with coronary artery disease, this breakthrough solution promises to revolutionize the way we manage heart health.
After years of hard work and dedication, HeartBeam is thrilled to announce the submission of its 510(k) application for the HeartBeam AIMIGo VECG device. This cutting-edge technology, which is powered by HeartBeam’s patented VECG technology, is designed to provide patients and their clinicians with accessible and actionable information. We are proud of the progress that has been made and look forward to working with the FDA as they review this application.
This year is a pivotal moment for HeartBeam, as we submit our product to the FDA and begin clinical studies on the system’s ability to synthesize a 12-lead ECG from our VECG signal. With our recent $26.5 million capital raise, we are now able to accelerate our clinical studies and move forward with our FDA submission, providing clinicians with the output they need to effectively evaluate cardiac patients.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is revolutionizing the way cardiac care is delivered, with the first-ever 3D-vector ECG platform designed for patient use at home. Utilizing their suite of proprietary algorithms, the HeartBeam platform allows patients and their clinicians to quickly and easily assess their cardiac symptoms, so any necessary care can be expedited.
With two patented products in development, HeartBeam AIMI™ and HeartBeam AIMIGo™, this cutting-edge technology is sure to change the way cardiac care is provided. Although these products have yet to be cleared by the U.S. Food and Drug Administration (FDA) for marketing in the USA or other geographies, their potential to revolutionize the industry is undeniable.