Deficiencies of the EU Medical Device Regulation when applying its own rules. [PDF]
Haimerl M +4 more
europepmc +1 more source
Hydrogel Microtube Drug Carrier for Catheter‐Based Intravascular Therapy
This paper proposes hydrogel microtube carriers composed of barium alginate gel, enabling long‐term vascular retention without interrupting blood flow. Intravascular treatments have long been attracting attention for therapeutic efficacy, yet practical delivery methods remained unestablished.
Shota Sato +8 more
wiley +1 more source
Advancing Public Health Through Internationally Coordinated Medical Device Registries Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". [PDF]
Mauch H.
europepmc +1 more source
Gonzalez Martinez and collaborators develop a strategy to formulate high performance GelMA‐based bioinks with low solids contents. The resulting bioinks enable 3D bioprinting at 37 °C of high‐fidelity structures with tunable mechanical properties that support high cell viability and function.
David A. González‐Martínez +8 more
wiley +1 more source
Surveillance and assessment of medical device-associated adverse events in a tertiary care hospital: An observational study. [PDF]
T V +5 more
europepmc +1 more source
This review examines how cellular behavior is regulated by mechanical cues transmitted through soft biomaterials, from single‐cell mechanosensing to tissue‐level adaptation. It highlights why physiological relevance, rather than model complexity alone, is critical for translational mechanobiology and introduces a scoring framework linking material ...
Mathias Polz +9 more
wiley +1 more source
Kalinix<sup>®</sup>, an innovative, intelligent, non-invasive, and self-adaptive medical device for effective OSA management. [PDF]
Hermosa JLR +6 more
europepmc +1 more source
A biocompatible sodium alginate‐based hydrogel is developed as a next‐generation submucosal lifting agent intended for EMR and ESD. The optimized formulation exhibits a composition devoid of endotoxins, high viscosity, demonstrates reliable injectability, and ensures prolonged mucosal elevation.
Iram Maqsood +9 more
wiley +1 more source
Comparison of approaches for quantifying extractables in a variety of polymeric medical device materials with LC-MS/MS. [PDF]
Niehuus AL +5 more
europepmc +1 more source

