Results 131 to 140 of about 454,812 (304)

Cardiac‐Derived ECM Microspheres for Enhanced hiPSC‐CMs Maturation

Advanced Functional Materials, EarlyView.
Cardiac extracellular matrix microspheres derived from decellularized porcine heart provide a biomimetic 3D microenvironment for human induced pluripotent stem cell–derived cardiomyocytes (hiPSC‐CMs). This platform supports short‐ and long‐term culture, enhances structural organization, and promotes electrophysiological and functional maturation of ...
Jiazhu Xu, Joel Aboagye, Marcella Edwards, Nick Rogozinski, Yufeng Wen, Angello Huerta Gomez, Zui Pan, Ge Zhang, Huaxiao Yang, Yi Hong   +9 more
wiley   +1 more source

In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)? [PDF]

Pathologica, 2021
Barberis M.
europepmc   +1 more source

Injectable Dual‐Network Hydrogel System for Osteochondral Repair Combining Immunomodulation, Mechanical Adaptability, and Enhanced Tissue Integration

Advanced Functional Materials, EarlyView.
A UV‐triggered injectable dual‐network hydrogel is reported as the first application of bletilla striata polysaccharide (BSP) in osteochondral repair. By integrating methacrylamide‐modified BSP and nitrobenzaldehyde‐functionalized hyaluronic acid, the system achieves immunomodulation, mechanical reinforcement, and dynamic tissue adhesion, thereby ...
Jiaming Cui, Feifei Zhou, Yuan Luo, Tao Ouyang, Huiwu Zhang, Songmiao Cheng, Qiang Li, Xu Jiang, Yingying Yu, Yicheng Wang, Hong Ming   +10 more
wiley   +1 more source

Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations

Frontiers in Neurology
Freezing of Gait (FOG) is a disabling motor symptom that affects a majority of individuals with advanced Parkinson's disease, severely limiting mobility, independence, and quality of life.
Alessandro Schaer, Henrik Maurenbrecher, Carlo Mangiante, Roman Sobkuliak, Kathrin Müsch, Paula Sanchez Lopez, Eduardo Martin Moraud, Eduardo Martin Moraud, Olgac Ergeneman, George Chatzipirpiridis   +9 more
doaj   +1 more source

IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation. [PDF]

BMJ Surg Interv Health Technol, 2021
Fleetcroft C, McCulloch P, Campbell B.
europepmc   +1 more source

Medical Devices Regulation [PDF]

, 2021
openaire   +1 more source

FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot [PDF]

, 2008
The project of harmonizing tort law and regulatory law in the public interest-the sweet spot of my subtitle-is inherently fraught with difficulty. This, of course, is a very old problem for American law generally.
Schuck, Peter H.
core   +1 more source

VIVID: A qPCR‐Based Platform for Sensitive and Quantitative In Vivo Tracking of Extracellular Vesicles

Advanced Functional Materials, EarlyView.
This study introduces VIVID (Vesicle In Vivo Identification using DNA), a qPCR‐based platform that tracks PCR‐amplifiable DNA tags loaded in the EVs for accurate and quantifiable EV biodistribution in vivo. ABSTRACT Extracellular vesicles (EVs) represent promising carriers for nucleic acid therapeutics, offering advantages over synthetic nanoparticles ...
Oscar Boyadjian, Talin Ebrahimian, Jonathan Miranda O'Connor, Janusz Rak, Stephanie Lehoux, Maryam Tabrizian   +5 more
wiley   +1 more source

Medical device similarity analysis: a promising approach to medical device equivalence regulation

Expert Review of Medical Devices
This study aims to facilitate the identification of similar devices for both, the European Medical Device Regulation (MDR) and the US 510(k) equivalence pathway by leveraging existing data. Both are related to the regulatory pathway of read across for chemicals, where toxicological data from a known substance is transferred to one under investigation ...
Jan Sündermann, Joaquin Delgado Fernandez, Rupert Kellner, Theodor Doll, Ulrich P. Froriep, Annette Bitsch   +5 more
openaire   +2 more sources

After Heparin: Protecting Consumers From the Risks of Substandard and Counterfeit Drugs [PDF]

, 2011
Based on case studies, examines globalization and quality management trends in pharmaceutical manufacturing, barriers to Federal Drug Administration oversight, and the security of pharmaceutical distribution.

core