Jan. 6, 2026 — Stereotaxis, a supplier of surgical robotics for minimally invasive endovascular intervention, has obtained U.S. Food and Drug Administration (FDA) approval for the MAGiC Magnetic interventional ablation catheter.

Jan. 5, 2026 — Medera Inc., a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, has announced that the final patient has been dosed in Cohort B (high-dose cohort, 4.50×10¹³ viral genomes (vg) per patient) of the ongoing MUSIC-HFpEF Phase 1/2a clinical trial evaluating SRD-002 gene therapy for heart failure with preserved ejection fraction (HFpEF).

Dec. 22, 2025 — Abbott recently announced the U.S. Food and Drug Administration (FDA) has approved the company's Volt PFA System to treat patients battling atrial fibrillation (AFib). Abbott will soon begin commercial PFA cases in the United States and will continue its expansion of sites in the European Union following Volt CE Mark approval earlier this year.

Dec. 12, 2025 —  Increased volume of epicardial adipose tissue, detected by cardiovascular imaging, was found to be associated with greater myocardial injury after a myocardial infarction.1 These findings were presented in December at EACVI 2025, the congress of the European Association of Cardiovascular Imaging (EACVI), a branch of the European Society of Cardiology (ESC). 

Cardiovascular diseases are the leading cause of death globally, accounting for around one-third of all deaths, of which 85% are due to myocardial infarction (MI) and stroke.2 

Dec. 26, 2025 — Edwards Lifesciences has announced the company’s SAPIEN M3 mitral valve replacement system, a transcatheter therapy using a transseptal approach, has received U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR).

Dec. 16,2025 — The European Society of Cardiology (ESC) has welcomed the adoption of the Safe Hearts Plan, a landmark step toward tackling Europe’s leading cause of death. This marks the culmination of a four-year effort by the ESC and the European Alliance for Cardiovascular Health (EACH) to help the European Commission develop a dedicated plan for Europe’s most important killer. 

Dec. 16, 2025 — McCrae Tech has launched the world’s first health AI orchestrator called Orchestral. It is a health-native AI orchestrator data platform that seamlessly connects diverse data sources with AI agents, workflows and algorithms — enabling scalable, governed AI deployment across healthcare systems.  

"Most information technology in healthcare falls into two camps: either a big, dumb bucket of cloud data or isolated pockets of AI cleverness," said Ian McCrae, founder of McCrae Tech. "We have created something vastly different that reshapes healthcare as we know it."

Dec. 18, 2025 — Heartflow, Inc., a provider of AI technology for coronary artery disease (CAD), has announced the American College of Cardiology (ACC) and the American Heart Association (AHA) published new scientific statements supporting the prognostic value of quantifying coronary plaque and reinforcing the critical role of the coronary computed tomography angiography (CTA) + Heartflow pathway in CAD patient management.

Dec. 18, 2025 — Huxley Medical has announced the SANSA home sleep apnea test has received regulatory clearance from the United States Food and Drug Administration (FDA) to be used as a diagnostic ECG monitor, making SANSA the first home sleep apnea test capable of offering diagnostic insight into cardiac arrhythmias, such as atrial fibrillation, from a single chest-worn patch.

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