- In May 2025, AccurKardia, a leading digital health company, announced that its AccurECG platform was named the Best New Technology Solution for ECG at the 9th Annual MedTech Breakthrough Awards. This FDA-cleared, device-agnostic software solution delivers near real-time, beat-by-beat ECG interpretation and supports a wide range of cardiac monitoring devices. By integrating with both short-duration and multi-day ECG systems, AccurECG enhances diagnostic accuracy and clinician workflows, positioning AccurKardia at the forefront of innovation in the Electrocardiogram (ECG/EKG) Band market
- In March 2025, Powerful Medical, a healthtech company specializing in AI diagnostics, received FDA Breakthrough Device Designation for its PMcardio STEMI AI ECG tool. This tool offers early detection of ST-elevation myocardial infarction (STEMI) and its equivalents using AI-driven ECG analysis. The model is designed for use in primary care and emergency settings, aiming to accelerate critical diagnoses and reduce time to treatment, reinforcing the role of AI-integrated ECG technologies in emergency cardiovascular care
- In January 2025, HeartBeam Inc. obtained FDA 510(k) clearance for its compact, credit card-sized ECG device, intended for home use. The device captures 3-lead ECG signals through five electrodes and transmits them to a smartphone app for conversion into a physician-ready 12-lead ECG. This development is a significant step toward remote cardiac monitoring, supporting the rising demand for accessible, patient-centric cardiovascular diagnostics
- In January 2025, Yale School of Medicine researchers unveiled an AI-powered tool capable of predicting the risk of heart failure based on standard 12-lead ECG images. This breakthrough supports early intervention strategies and personalized care by identifying high-risk individuals before clinical symptoms manifest, reflecting the growing importance of predictive analytics in the Electrocardiogram (ECG/EKG) Band market
- In January 2025, the Centers for Medicare & Medicaid Services (CMS) included AI-ECG technologies in its reimbursement schedule under the 2025 Hospital Outpatient Prospective Payment System. This regulatory update facilitates broader adoption of AI-driven ECG tools by enabling reimbursement for algorithms such as Tempus’ ECG-AF and Anumana’s ECG-AI, thereby accelerating clinical integration and market growth
