FDA clears Corvention’s KardiaPSI Balloon Catheter as structural heart tools get more specialized

Calcified aortic valves need force and control. Corvention’s KardiaPSI clearance tests whether niche BAV tools can scale clinically.

Calcified aortic valves need force and control. Corvention’s KardiaPSI clearance tests whether niche BAV tools can scale clinically.

Find out how Reflow Medical’s Cora Flex and Cora Force launch could reshape complex coronary intervention workflows.

Pulnovo Medical raised $100 million with Medtronic backing. Read what it means for PADN, pulmonary hypertension, heart failure, and device markets.

BD secures EU CE Mark for the Revello vascular covered stent for iliac artery disease. Explore what this device could change for PAD treatment in Europe.

Mitria Medical’s Subvalvular Spacer reaches the U.S. under FDA compassionate use. What it means for FMR patients and what clinical evidence still needs to come.

Vesalio has received 510(k) clearance from the U.S. Food and Drug Administration for enVast, its stent-based coronary clot retrieval system, making it the first device of its kind approved for mechanical thrombectomy in the cardiac circulation. The approval authorizes enVast for U.S. commercialization, following prior regulatory clearance and use in European markets. The device is […]