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The Sim&SizeTM software product represents a significant advancement in the treatment of brain aneurysms. Designed with a patient-centric approach, the platform enables to model sophisticated therapeutic strategies and visualize diverse treatment options, ranging from flow diverters and intrasaccular devices, to coils and support stents. Today, Sim&SizeTM proudly stands as a beacon of innovation with over 20,000 optimized neurovascular procedures across 40+ countries, marking a global milestone in advancing healthcare practices.
With its cutting-edge technology and meticulous design, Sim&SizeTM has undergone rigorous testing and evaluation to meet the stringent requirements set forth by the European Union's new Medical Device Regulation.
The CE marking certification under the MDR underscores Sim&Cure's unwavering commitment to quality, safety, and efficacy in the development and manufacturing of medical devices. This milestone not only demonstrates our dedication to meeting regulatory standards but also affirms our dedication to providing healthcare professionals and patients with innovative solutions that enhance quality of life and patient care.
"We are thrilled to announce the attainment of the CE marking for our Sim&SizeTM software under the new Medical Device Regulation," said Mathieu Sanchez, Chief Executive Officer (CEO) at Sim&Cure. "This achievement is a testament to our team's hard work, expertise, and dedication to delivering superior products that meet the highest standards of safety and effectiveness."
The CE marking allows Sim&Cure to continue to market and distribute the Sim&SizeTM software within the European Economic Area (EEA), reaffirming its compliance with essential health and safety requirements outlined in the MDR. This certification not only opens up new opportunities for Sim&Cure but also reinforces our commitment to serving healthcare professionals and patients across the globe.
"I'm thrilled and proud of our Sim&Cure team for achieving this milestone! With this CE Mark MDR certification, we're set to swiftly release new features and software enhancements.” Said Christophe Chnafa, Chief Innovation & Strategy Officer at Sim&Cure. “It sets the stage for our continued growth through our existing portfolio and the pipeline of innovative technologies we've been developing. It also demonstrates again our dedication to providing physicians with reliable software for optimal treatment strategies that meet the highest quality standards.”
For more information about Sim&Cure and its innovative product offerings, please visit: https://sim-and-cure.com/
Established in 2014, Sim&Cure has become a leading force in the dynamic Medtech landscape of Montpellier, France. Focused on transforming aneurysm management, the company integrates Digital Twin and AI technologies to reshape patient care. Their journey emphasizes continuous growth and achievements, driven by a dedication to improving healthcare outcomes. Sim&Cure envisions a future where haemorrhagic stroke is eliminated, reflecting their commitment to a holistic transformation in healthcare for both doctors and patients.
Manon Howells, Product Marketing Manager EMEA
Sim&Cure
[email protected]
+33767775419
