8F ABLATION CATHETER PORTFOLIO
Khelix™ Diagnostic Electrophysiology Catheter
Our catheters are available in a range of shapes and configurations to support both ablation and diagnostic procedures. Designed for precision and control, each device integrates seamlessly into EP workflows, whether you’re mapping complex arrhythmias or delivering targeted therapy.
KHELIX™ LOOP EP CATHETERS
KHELIX™ STEERABLE EP CATHETERS
KHELIX™ FIXED EP CATHETERS
Commercialised Products & Regulatory Approvals
CathRx’s diagnostic catheter portfolio has regulatory approvals across major markets including Australia (TGA), New Zealand (MedSafe), Europe (CE Mark), USA (FDA 510K), Korea (MFDS), Taiwan (TFDA), and Thailand (Thai FDA).
CathRx operates under a Quality Management System (QMS) which is ISO 13485:2016, MDSAP (Australia, Brazil, Japan, and United States), and EC – Full Quality Assurance System certified.
Commercial sales of the Khelix diagnostic catheter system started in 2024 from the company’s pilot manufacturing facility in Sydney (Australia).
We are on schedule to commence supporting larger customer orders from our contract manufacturing facility in Chiayi (Taiwan) from Q4 2025.
Regulatory Approval Status
