April 7, 2025 — CardioVia, a medical device company specializing in advanced cardiac care solutions, has received U.S. Food and Drug Administration (FDA) clearance for its ViaOne system. This device is designed to enable safe and precise access to the heart’s surface (pericardial space) for both diagnostic and therapeutic interventions — without using an exposed needle. By eliminating the need for an uncontrolled sharp needle, ViaOne mitigates the risk of heart perforation, a well-recognized complication associated with current percutaneous techniques.