CardioVia, a medical device company specializing in cardiac care solutions, said it has received FDA clearance for its ViaOne system. The device is designed to enable safe and precise access to the heart's surface (pericardial space) for both diagnostic and therapeutic interventions — without the use of an exposed needle.
Prior to this FDA clearance, ViaOne had already attracted attention, by receiving and taking part in the FDA's Breakthrough Device Designation (BDD) program, recognizing its potential to deliver more effective treatments for patients with complex cardiac arrhythmias
"This FDA clearance represents a pivotal milestone in our mission to redefine how cardiac interventions are performed," said CEO Ziv Menshes. 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."
The FDA clearance is supported by clinical evidence, including a recent study published in a medical journal - JACC: Clinical Electrophysiology, demonstrating ViaOne's safety profile and effectiveness.
CardioVia is now preparing for the initial commercial launch of ViaOne at leading cardiac centers across the United States, with plans to integrate the technology into major healthcare networks and expand its availability to a broader patient population.
