The Latest Cardiac and Vascular News
HeartBeam Enters New Growth Phase Following FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment First Commercial Partner ClearCardio™ to Bring HeartBeam’s 3D ECG Technology to High-Growth Preventive Cardiology Market First Patients Enrolled in Heart Attack Detection Pilot Study, A Key Step Toward Future FDA Indication Expansion […]
HeartBeam’s technology uniquely capable of assessing possible heart attacks outside of traditional clinical settings ALIGN-ACS study expected to complete patient enrollment quickly Milestone signifies key step toward future FDA indication expansion for heart attack assessment Future indication expansion would unlock large market with over 20 million patients at risk of a […]
SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam Announces First Commercial Customer as ClearCardio Brings Groundbreaking 12-Lead ECG Technology to High-Growth Preventive Cardiology Market
December 10, 2025 7:00am ESTDownload as PDF FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients Anytime, Anywhere Pivotal Milestone Unlocks Multiple Key Initiatives in Company’s Growth Strategy SANTA CLARA, Calif.–(BUSINESS WIRE)– HeartBeam, Inc. (NASDAQ: BEAT), a […]
Commercial Readiness Plans Accelerating in Anticipation of FDA 510(k) Clearance for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software for Arrhythmia Assessment Anticipated FDA Clearance in Q4 2025 is a Major Inflection Point as HeartBeam Evolves into a Commercial-Stage Company Focused on Growth Announced Partnership with HeartNexus to Provide On-Demand Cardiologist Reviews […]
FDA-cleared technology makes clinical-grade ECG insights for arrhythmia assessment available outside of a medical facility SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it has been awarded the Innovation Award in Remote Cardiac Diagnostics as part […]
Milestone results formed the basis of HeartBeam’s 12-lead ECG synthesis software application submitted to FDA in January 2025 SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc., (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that its groundbreaking synthesized 12-lead electrocardiogram (ECG) successfully met the […]
Received FDA Clearance for the HeartBeam System – an At-Home, High-Fidelity Heart Monitoring Technology Commenced Early Access Program to Attain Key Insights and Establish Sales Funnel in Preparation for Commercialization Submitted 510(k) Application to FDA for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software Gross Proceeds of ~$11.5 Million from Public Offering […]
February 25, 2025 04:01 PM Eastern Standard Time SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that the underwriter of its previously announced public offering of HeartBeam’s common stock has exercised its option to purchase an […]
HeartBeam system was recently cleared by the U.S. Food and Drug Administration (FDA) for comprehensive arrhythmia assessment 510(k) application submitted to the FDA for the Company’s groundbreaking 12-lead electrocardiogram (ECG) synthesis software Funding is part of the Company’s strategic plan focusing on key growth milestones and preparation for U.S. commercialization […]
