CardioVia Receives FDA Clearance for ViaOne Cardiac Device

June 2025

CardioVia Announces FDA Clearance for ViaOne, Opening a New Frontier in Minimally Invasive Heart-Surface Treatments

CardioVia received FDA 510(k) clearance for its ViaOne™ Epicardial Access System, following its earlier FDA’s Breakthrough Device Designation. This milestone validates the safety and effectiveness of ViaOne as a minimally invasive device that provides controlled access to the heart’s surface. FDA clearance paves the way for U.S. commercialization and supports adoption of more effective treatments for arrhythmias and other cardiac conditions.

The FDA clearance cardiac device approval confirms the potential of ViaOne™ to transform cardiac interventions. Designed to provide safe and precise access to the pericardial space for diagnostic and therapeutic use, ViaOne™ eliminates the need for an exposed needle — reducing the risk of cardiac perforation associated with traditional percutaneous techniques.

Prior to receiving FDA clearance, ViaOne was part of the FDA’s prestigious Breakthrough Device Designation program, recognizing its potential to improve outcomes for patients with complex cardiac arrhythmias.

“This FDA clearance represents a pivotal milestone in our mission to redefine how cardiac interventions are performed,” said Ziv Menshes, CEO of CardioVia. “ViaOne is not just a product, it’s a platform that opens the door to a new era of heart-surface therapies, improving safety and outcomes for patients worldwide.”

“CardioVia’s device simplifies access to the heart surface, paving the way for a major shift in the field,” added Prof. David Luria, Director of Electrophysiology at Hadassah Medical Center.

The FDA clearance cardiac device approval is supported by strong clinical evidence, including a recent publication in JACC: Clinical Electrophysiology, demonstrating ViaOne’s safety and effectiveness.

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