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Valcare Medical Receives FDA Approval to Initiate Early Feasibility Study for its Novel AMEND™ Trans-Septal System

HERZLIYA, Israel and WILMINGTON, Del., March 13, 2025 /PRNewswire/ — Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMEND™ Trans-Septal System for investigational device exemption (IDE) application to commence an Early Feasibility Study (EFS).

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Elute Earns U.S. FDA Clearance for Its Novel Synthetic Resorbable Bone Void Filler

SALT LAKE CITY, March 12, 2025 /PRNewswire/ — For the thousands of patients in the United States requiring treatment for bone loss or defects caused by trauma or infections, Elute, Inc., a clinical stage company and emerging leader with a groundbreaking controlled and extended drug delivery platform, proudly announces U.S. Food and Drug Administration (FDA) approval of BonVie+™, a novel bone void filler implant.

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