CathWorks Receives EU MDR Approval, Showcases at EuroPCR, and Launches Co-promotion Initiative

Tuesday, May 14, 2024

CathWorks shared exciting news: their CathWorks FFRangio® System has gained approval under the European Union (EU) Medical Device Regulation 2017/745, also known as EU MDR, and has received the CE marking (0344), indicating compliance with EU standards.

EU MDR, a comprehensive update to Europe's medical device regulations, replaces the former Medical Device Directive 93/42/EEC (MDD).

This new regulation places heightened emphasis on safety protocols, risk management, post-market surveillance, and data collection for medical device companies seeking European market access.

This milestone coincides perfectly with the European launch of CathWorks' co-promotion partnership with Medtronic, which will be showcased at EuroPCR this week.

The CathWorks FFRangio technology will take center stage at the EuroPCR conference in Paris, France, from May 14 to 17.

Multiple scientific sessions will spotlight the FFRangio System, showcasing its pivotal role in revolutionizing the diagnosis and treatment of coronary artery disease.

Noteworthy presentations include Dr. Yuetsu Kikuta's abstract on FFRangio-based PCI's superior 1-year clinical outcomes, and Dr. Kazuhiro Dan's comparison between FFRangio sizing tool and IVUS imaging measurements for PCI.

As part of their collaboration, CathWorks and Medtronic will co-sponsor a symposium titled "CathWorks FFRangio – Enhancing Patient Care," led Imperial College London and Columbia University Irving Medical Center.

This symposium, featuring esteemed experts, will explore the seamless integration of FFRangio into clinical practice and its impact on decision-making for patients with coronary artery disease.


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