NeoDynamics is proud to announce the launch of a device registry in Germany for its NeoNavia Biopsy System. The registry, which has recently seen the first procedure documented, is a key initiative in collecting real-world data and will be rolled out to several hospitals across Germany This effort not only demonstrates our commitment to cost efficiency but also supports compliance with the stringent post-market surveillance requirements mandated by the Medical Device Regulation (MDR).
The NeoNavia Biopsy System, renowned for its precision and precision in biopsy procedures, will now be further evaluated through real-world data collected from this registry. This data will encompass all three needle types used in the system, providing a comprehensive understanding of its performance across various clinical scenarios.
Conventional clinical studies, while comprehensive, often involve significant resources and expenses. By adopting a registry-based approach, NeoDynamics embraces a more sustainable method for continuous data collection.
Dr. Kai-Uwe Schässburger, Director of Clinical Development and Medical Affairs at NeoDynamics, emphasized the strategic importance of the registry, stating, 'This initiative not only showcases our commitment to cost-efficient solutions to comply with regulatory requirement but also positions us to leverage the collected real-world data for impactful medical communication."