- In May 2022, BioSig Technologies, Inc., a prominent medical technology company, initiated a commercial campaign for its FDA 510(k)-approved PURE EP system. This advanced device is designed to enhance procedural efficiency in cardiac electrophysiology. The introduction of the PURE EP system represents a key innovation aimed at improving the accuracy and effectiveness of electrophysiological procedures, thereby addressing the growing demand for advanced, minimally invasive cardiac treatments worldwide
- In November 2021, India Medtronic Private Limited, a subsidiary of Medtronic plc, launched the Arctic Front Cardiac Cryoablation Catheter System in India. This groundbreaking system, approved by the Central Drugs Standard Control Organization (CDSCO), is the first cryoballoon catheter specifically designed for the treatment of atrial fibrillation in the country. The introduction of the Arctic Front Cryoablation Catheter reflects the ongoing innovation in minimally invasive treatments for atrial fibrillation
- In December 2020, Acutus Medical received the CE Mark for its AcQBlate Force Sensing Ablation System, allowing its availability in Europe. This advanced system, designed for electrophysiology mapping and radiofrequency (RF) ablation, features a gold-tipped, irrigated, force-sensing radiofrequency ablation catheter, underscoring Acutus's commitment to innovative cardiac intervention technologies. The approval and subsequent launch of the AcQBlate System are highly significant for the global electrophysiology market, as it introduces a next-generation solution that enhances the precision and efficacy of atrial fibrillation treatments
- In August 2023, Biosense Webster received regulatory approval for a range of atrial fibrillation ablation products designed for use in fluoroscopy-free workflows during catheter ablation procedures. The approval of these products responds to the growing demand for safer, more efficient procedures with reduced radiation exposure
- In May 2023, Abbott received approval from the U.S. Food and Drug Administration (FDA) for its TactiFlex Ablation Catheter, Sensor Enabled. This pioneering catheter is the first to feature both contact force technology and a flexible tip. Designed to treat atrial fibrillation (AFib), the TactiFlex catheter offers reduced procedure times and enhanced safety compared to previous-generation catheters. The approval of the TactiFlex catheter exemplifies the ongoing innovation in electrophysiology devices. By improving procedural efficiency and patient safety, the TactiFlex catheter aligns with the increasing demand for advanced, minimally invasive solutions for cardiac arrhythmias, further driving the growth of the electrophysiology market worldwide
