Protaryx Medical Receives FDA 510(k) Clearance for Its Breakthrough Transseptal Puncture Device

By Protaryx | April 14, 2026

Baltimore, Maryland – April 13, 2026 – Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the proprietary Transseptal Puncture Device. This milestone represents a significant advancement in the Company’s…

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Protaryx Medical Achieves Milestone with Successful Completion of First-in-Human Study of an Innovative Transseptal Puncture Technology

By Protaryx | December 11, 2024

Baltimore, Maryland – December 11, 2024 – Protaryx Medical, a pioneer in medical device innovation, is proud to announce the successful completion of its First-in-Human (FIH) study, demonstrating the transformative potential of its advanced transseptal puncture technology. Conducted on December 3, 2024, at Sanatorio Italiano de Asunción in Paraguay, the study enrolled five patients under…

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