#USA #Madrid #FDA Clearance #Corify Care #ACORYS®

Corify Care Secures FDA Approval for ACORYS® Cardiac Mapping System

Corify Care, a prominent player in the MedTech industry, has marked a significant milestone in cardiac electrophysiology by receiving clearance from the U.S. Food and Drug Administration (FDA) for its innovative ACORYS® System. This groundbreaking technology represents the first imageless, non-invasive cardiac mapping platform that can provide a comprehensive view of cardiac electrical activity across all four chambers in real-time.

Revolutionizing Electrophysiology

The introduction of the ACORYS® System signals a paradigm shift in the field of electrophysiology. By combining high-resolution, three-dimensional anatomical models with real-time electrical activity, this system facilitates a true four-dimensional cardiac mapping experience. This capability enables medical professionals to gain immediate insights into the functional characteristics of the heart, enhancing the speed, safety, and accuracy of ablation procedures.

Designed to seamlessly integrate into existing electrophysiology workflows, ACORYS empowers healthcare providers with rapid, panoramic mapping of complex arrhythmia mechanisms. The platform allows clinical teams to assess arrhythmia complexity in real-time without the need for pre-procedural imaging or the induction of unstable arrhythmias, which often complicate treatment.

Andreu Climent, PhD, the CEO of Corify Care, expressed that obtaining FDA clearance is a defining moment not only for Corify but for the entire landscape of electrophysiology. He stressed that traditional mapping techniques have been constrained by incomplete data and time-consuming processes. In contrast, ACORYS provides immediate insights that allow for informed decision-making from the onset of the procedure.

Key Features of ACORYS

The innovative ACORYS® System is characterized by several significant features that bolster its appeal to healthcare professionals:

• - Single-Beating Global Cardiac Mapping: The system offers a comprehensive view of cardiac dynamics across all four chambers.
• - Imageless Workflow: It operates without the necessity for CT or MRI scans, simplifying the procedure.
• - Real-Time Functional Assessment: Whether pre-, intra-, or inter-procedural, ACORYS allows for real-time evaluation of arrhythmia complexity.
• - Non-Invasive Approach: The system complements standard catheter workflows while prioritizing patient safety.
• - Rapid Identification of Arrhythmogenic Substrate: It effectively detects issues such as ventricular tachycardia and complex atrial tachyarrhythmias.

ACORYS has already been validated in over 2,500 patients in leading electrophysiology centers throughout Europe and will showcase its new clinical data at the Heart Rhythm Society (HRS) 2026 conference in Chicago, running from April 23–26. The research presented has showcased impressive results in accurately identifying arrhythmia mechanisms, determining the origin of issues, and defining ablation targets seamlessly.

Dr. Felipe Atienza, CMO and Co-Founder of Corify Care, highlighted the unprecedented potential ACORYS offers clinicians by giving them a thorough understanding of arrhythmias even before commencing ablation procedures. He anticipates that this breakthrough will fundamentally alter approaches to complex cases of ventricular and atrial tachyarrhythmias.

Following the FDA clearance, Corify Care is poised to commence a phased rollout of its ACORYS® System in the United States, collaborating with top electrophysiology centers to facilitate widespread adoption and enhance patient outcomes.

About Corify Care

Corify Care is committed to redefining cardiac mapping by enabling global, whole-heart visualization. Their technology is designed to integrate effortlessly into current electrophysiology workflows, serving as a crucial tool in catheter ablation procedures. With the successful acquisition of FDA 510(k) clearance and compliance with European regulations (CE marking), Corify Care continues to push the envelope of innovation in the MedTech industry, ensuring that it remains at the forefront of advancements in cardiac care.

In conclusion, the ACORYS® System’s FDA clearance is an important step forward for both Corify Care and the broader field of electrophysiology, as it opens new avenues for effective cardiac arrhythmia treatment and fosters a more confident, precise approach to patient care.