Corify Care Gains FDA Clearance for ACORYS 4D Mapping

MADRID, Spain, April 2026

Corify Care has achieved a major regulatory milestone with U.S. FDA 510(k) clearance for its ACORYS® System, an innovative, imageless and non-invasive cardiac mapping platform capable of delivering real-time, four-dimensional (4D) electroanatomical mapping of the heart. This breakthrough introduces a global, single-beat visualization of cardiac electrical activity across all four chambers, representing a transformative advancement in electrophysiology (EP) and arrhythmia management. By combining high-resolution 3D anatomical reconstruction with real-time electrical data, ACORYS enables clinicians to gain instant functional insight, improving both diagnostic accuracy and procedural efficiency in complex cardiac cases.

Real-Time 4D Mapping Transforms Electrophysiology Practice

The ACORYS® System marks a significant shift from traditional contact-based and time-intensive mapping techniques by providing instant, panoramic cardiac mapping without the need for CT or MRI imaging. This imageless workflow allows physicians to assess arrhythmias pre-procedurally, intra-procedurally, and inter-procedurally, offering unprecedented flexibility and speed in clinical decision-making. The ability to generate global cardiac maps in a single heartbeat eliminates delays associated with conventional mapping and reduces the need to induce unstable arrhythmias during procedures.

Clinicians can now identify arrhythmogenic substrates such as ventricular tachycardia (VT) and complex atrial tachyarrhythmias in real time, enabling more precise targeting during ablation therapies. This results in faster, safer, and more predictable procedures, improving patient outcomes and reducing procedural risks. The system seamlessly integrates into existing catheter-based workflows, acting as a complementary tool rather than a replacement, thereby enhancing adoption across electrophysiology labs.

Strong Clinical Validation Across Complex Arrhythmias

The ACORYS platform has been validated in more than 2,500 patients across leading European electrophysiology centers, demonstrating high accuracy in identifying arrhythmia mechanisms, chamber origin, and ablation targets. Clinical data show that the system can localize ventricular tachycardia substrates even in sinus rhythm, significantly reducing the need for inducing potentially dangerous arrhythmias during procedures.

Additionally, the technology enables precise mapping of atrial activation patterns, supporting improved treatment strategies for patients with atrial fibrillation and other complex arrhythmias. These capabilities highlight the system’s ability to provide comprehensive cardiac insights before intervention begins, fundamentally changing how clinicians approach diagnosis and treatment planning. The upcoming presentation of new data at the Heart Rhythm Society (HRS) 2026 conference in Chicago is expected to further reinforce the platform’s clinical value and performance across diverse patient populations.

Regulatory Milestone Supports U.S. Commercial Expansion

With FDA clearance secured, Corify Care is set to initiate a phased commercial rollout in the United States, collaborating with leading electrophysiology centers to accelerate adoption of its next-generation mapping technology. The system already complies with European CE marking requirements, positioning it as a globally validated solution for advanced cardiac care.

The approval reflects growing regulatory recognition of non-invasive, software-driven medical technologies that enhance clinical precision and workflow efficiency. ACORYS also aligns with ongoing innovation trends in digital health, real-time diagnostics, and minimally invasive cardiology, reinforcing its relevance in modern healthcare systems.

By delivering comprehensive, real-time visualization of cardiac electrical activity, ACORYS empowers clinicians to understand arrhythmia complexity, define treatment targets, and act with confidence from the very first beat, significantly improving both procedural success rates and patient safety.

The FDA clearance of the ACORYS® System represents a pivotal advancement in cardiac electrophysiology and medical device innovation, introducing real-time 4D mapping capabilities that redefine arrhythmia diagnosis and treatment. With its non-invasive design, strong clinical validation, and seamless workflow integration, Corify Care is positioned to lead the next generation of precision cardiology technologies, transforming how clinicians manage complex cardiac conditions worldwide.

Source: Corify Care press release