Latest Cardiology News

EBR Systems reported a doubling of WiSE System implants in Q4 FY2025 alongside the launch of key clinical studies and preliminary revenue guidance, signalling strong commercial and clinical momentum.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its Vision-MR Diagnostic Catheter, paving the way for commercial sales in the US electrophysiology market.

Artrya Limited has signed a significant five-year commercial agreement with Cone Health, marking its third U.S. customer and solidifying its foothold in the American healthcare market with its AI-powered Salix platform.

Imricor Medical Systems has secured Charité University Hospital in Berlin as the second global site for its VISABL-VT clinical trial, marking a significant milestone in real-time MRI-guided cardiac ablation technology.

Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.

EBR Systems has completed the first patient implant in its Totally Leadless CRT (TLC-AU) feasibility study, marking a strategic step toward expanding wireless cardiac resynchronisation therapy for heart failure patients.

Artrya Limited has landed a significant three-year commercial agreement with Northeast Georgia Health System, marking its second U.S. customer for the AI-powered Salix platform. This deal accelerates Artrya’s footprint in cardiovascular diagnostics across a major U.S. health network.

Echo IQ has completed a pivotal clinical validation of its EchoSolv HF software at the Mayo Clinic, achieving outstanding accuracy ahead of its FDA submission. This milestone sets the stage for potential US market entry into a $60 billion heart failure diagnostics sector.

Artrya Limited has expanded its SAPPHIRE clinical study with Ascension, one of the largest US non-profit health systems, joining as the fourth major participant. This move strengthens the study’s reach and advances the evaluation of Artrya’s AI-powered Salix platform for coronary artery disease detection.

Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.

Artrya secures participation from Mass General Brigham, a leading U.S. cardiovascular research center, in its pivotal SAPPHIRE Study launching in early 2026. This collaboration aims to validate Artrya’s AI-powered Salix platform for earlier and more effective coronary artery disease detection.