Israeli medtech company CardioVia announced it has received FDA clearance for its ViaOne system, a minimally invasive device that enables safe access to the heart’s surface without using an exposed needle
The breakthrough platform, designed to reduce the risk of heart perforation, had previously earned the FDA’s prestigious Breakthrough Device Designation.
Backed by strong clinical evidence, ViaOne is expected to transform the treatment of cardiac arrhythmias and improve outcomes for millions.
CardioVia plans an initial U.S. rollout at leading heart centers. “This marks a major step toward safer, more effective heart-surface therapies,” said CardioVia CEO Ziv Menshes.
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