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Luma Vision wins FDA clearance for cardiac visualization platform

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This is a Luma Vision marketing image of its Verafeye catheter-based cardiac imaging system.
The Verafeye catheter-based cardiac imaging system [Image courtesy of Luma Vision]
Luma Vision recently announced that the FDA has cleared its Verafeye catheter-based cardiac imaging system.

The company — based in Dublin, Ireland, and Munich, Germany — describes Verafeye as a novel catheter-based imaging system that provides real-time, two and four-dimensional, 360-degree visualization, enhancing clinician precision and confidence during complex electrophysiology and structural heart procedures.

Luma Vision says it has prepared the system for magnetic tracking and navigation of third-party catheters. Other Verafeye features include imaging depths up to 120 mm away from the catheter and dynamic high-resolution navigation and visualization of the heart.

“Our clinical experience with Verafye is exciting, with the potential to simplify procedural workflow and efficiency,” Dr. Shephal Doshi, director of electrophysiology at Pacific Heart Institute/Cedars Sinai and investigator of the Verafeye system, said in a news release. “Real-time visualization and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity.”

Dr. Anish Amin, system medical chief for cardiac electrophysiology at OhioHealth Heart and Vascular, described Verafeye as a major advancement in intraprocedural cardiac imaging. “Verafeye’s imaging capabilities demonstrate a necessary path forward in precision imaging and a strong foundation to further advance the standard of care.”

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.