Posts by Protaryx
Protaryx Medical Receives FDA 510(k) Clearance for Its Breakthrough Transseptal Puncture Device
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…
Read MoreProtaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device
Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its proprietary Transseptal Puncture Device. This submission marks a major milestone in the Company’s mission to redefine safe, efficient and…
Read MoreProtaryx Medical Achieves Milestone with Successful Completion of First-in-Human Study of an Innovative Transseptal Puncture Technology
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…
Read MoreProtaryx Medical Welcomes David Mester as New CEO, Spearheading Innovative Advancements in Transseptal Access Technology
[Baltimore Maryland, September 11, 2023] – Protaryx Medical, a pioneering leader in medical device innovation, proudly announces the appointment of David Mester, MBA as its new Chief Executive Officer (CEO). With a remarkable career spanning over 30 years in the structural heart medical device industry, David Mester brings a wealth of experience and expertise to…
Read More