Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
, 2014 A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs) [PDF]
, 2020 Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few.
Bakker, Jessie +14 more
core +2 more sources
How to calculate the life cycle of high-risk medical devices for patient safety
Frontiers in Public Health, 2022 In this study, we analyzed Korean and foreign systems, focusing on high-risk medical devices that urgently need to be managed, and we present an life cycle calculation method for determining replacement time.
Gihong Seo +3 more
doaj +1 more source
Autonomic regulation therapy to enhance myocardial function in heart failure patients: the ANTHEM-HFpEF study. [PDF]
, 2017 BackgroundApproximately half of the patients presenting with new-onset heart failure (HF) have HF with preserved left ventricular ejection fraction (HFpEF) and HF with mid-range left ventricular ejection fraction (HFmrEF).
Amurthur, Badri +8 more
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The regulation of mobile health applications
BMC Medicine, 2012 In July 2011, the United States Food and Drug Administration issued draft guidance concerning the regulation of mobile medical applications (applications on a wireless device that are used as accessories to medical devices or to convert a mobile platform
Barton Amy J
doaj +1 more source
New medical device regulations: the regulator’s view
EFORT Open Reviews, 2019 Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device ...
Melvin, Tom, Torre, Marina
openaire +2 more sources
Using tablets to support self-regulated learning in a longitudinal integrated clerkship. [PDF]
, 2014 The need to train physicians committed to learning throughout their careers has prompted medical schools to encourage the development and practice of self-regulated learning by students.
Alegría, Dylan Archbold Hufty +4 more
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Dual targeting of RET and SRC synergizes in RET fusion‐positive cancer cells
Molecular Oncology, EarlyView.Despite the strong activity of selective RET tyrosine kinase inhibitors (TKIs), resistance of RET fusion‐positive (RET+) lung cancer and thyroid cancer frequently occurs and is mainly driven by RET‐independent bypass mechanisms. Son et al. show that SRC TKIs significantly inhibit PAK and AKT survival signaling and enhance the efficacy of RET TKIs in ...
Juhyeon Son +13 more
wiley +1 more source
Floating-disk parylene microvalve for self-regulating biomedical flow controls [PDF]
, 2008 A novel self-regulating parylene micro valve is presented in this paper with potential applications for biomedical flow controls. Featuring a free-floating bendable valve disk and two-level valve seat, this surface-micromachined polymeric valve ...
Chen, Po-Jui +3 more
core +1 more source
Exploiting metabolic adaptations to overcome dabrafenib treatment resistance in melanoma cells
Molecular Oncology, EarlyView.We show that dabrafenib‐resistant melanoma cells undergo mitochondrial remodeling, leading to elevated respiration and ROS production balanced by stronger antioxidant defenses. This altered redox state promotes survival despite mitochondrial damage but renders resistant cells highly vulnerable to ROS‐inducing compounds such as PEITC, highlighting redox
Silvia Eller +17 more
wiley +1 more source