A thermo‐responsive poly(2‐oxazoline)‐based injectable formulation is developed to modulate intraocular pressure (IOP) in both normal and hypotonic eyes. By adjusting the PEG content, the aggregation behavior is finely tuned, enabling IOP elevation without long‐term deposition.
Yuji Tanaka +2 more
wiley +1 more source
Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices.
Dabek PA +4 more
europepmc +1 more source
Innovative Clinical Trial Approach for Evaluating Digital Medical Devices Under European Fast-Track Regulatory Frameworks. [PDF]
Ursino M +10 more
europepmc +1 more source
A long‐lived, five‐cell‐type human neurovascular (PENTA) model recreates vascular disorganization and incomplete repair after traumatic brain injury (TBI). By integrating endothelial, glial, neuronal, and immune components within a 3D scaffold, the platform enables time‐resolved analysis of neurovascular remodeling and provides a human‐relevant system ...
Daniel S. Hinrichsen +6 more
wiley +1 more source
Orphan medical devices: addressing the regulatory and access gaps in the EU and US. [PDF]
Akodad S, Haon B, Rochaix L, Stevens H.
europepmc +1 more source
Design and Synthesis of Peptide‐Polyester Conjugates for Cell‐Mediated Scaffold Degradation
This work describes polycaprolactone (PCL)‐based biomaterials engineered to degrade in response to cell‐secreted proteases. A fast‐degrading peptide (Fast) sequence is integrated into a PCL conjugate backbone to produce a biomaterial that is selectively degraded by multiple cell types compared to its scrambled control (ScrFast).
Korina Vida G. Sinad +7 more
wiley +1 more source
Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. [PDF]
Menon V.
europepmc +1 more source
Multidimensional Cellular Micro‐Compartments to Model Invasive Lobular Carcinoma Dormancy
Invasive lobular carcinoma (ILC) is an understudied subtype of breast cancer that is susceptible to late recurrences. In this study, micro‐compartmentalization techniques spanning multiple dimensions, including 2D, pseudo‐3D, and 3D, are integrated to uncover the mechanisms underlying ILC dormancy, revealing the central role of p27Kip1.
Xilal Y. Rima +15 more
wiley +1 more source
Describing Inconsistencies in Pediatric Labeling of Medical Devices.
Zapotoczny G +7 more
europepmc +1 more source
Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. [PDF]
Ponnambalath Mohanadas H +4 more
europepmc +1 more source

