VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
Luma Vision LimitedThe VERAFEYE System by Luma Vision Limited is an advanced ultrasound imaging tool designed for real-time visualization inside the heart and great vessels during cardiac procedures. It includes a sterile catheter and an imaging console that creates 2D and 3D ultrasound images to help clinicians see cardiac anatomy and physiology, guiding interventions safely and accurately.
Intended Use
The VERAFEYE Imaging Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The VERAFEYE Imaging System is intended for cardiac applications creating 2D (B-mode) and 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate presence or absence of pathology. It also provides anatomical scale information to assist clinicians adjunctively with diagnostic data.
Technology
The system consists of an ultrasound imaging catheter with a 64-channel segmented aperture array transducer integrated within a steerable 11Fr catheter. It operates by transmitting ultrasound energy to acquire live 2D and 3D volumetric images. The system console includes a catheter interface unit and dual monitors for image display and manipulation by clinicians. The catheter allows for rotation, deflection, and insertion to obtain different imaging angles and real-time visualization. The system is compatible with existing ultrasound technologies and follows recognized safety standards (IEC 60601-1, IEC 60601-2-37, AIUM/NEMA standards).
Performance
Performance validation included bench and laboratory testing demonstrating safety and effectiveness equivalent to predicate devices (ACUSON AcuNav and SC2000 systems). Non-clinical data followed recognized standards for ultrasound safety, electromagnetic compatibility, and biocompatibility. No new clinical testing was included; performance equivalence established by detailed comparison.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/23/2024
6 months - 2
FDA Approval
3/24/2025
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