Frontiers in Cardiovascular Medicine, 2022 BackgroundDue to rapid medical and technological progress, more and more pediatric patients with terminal cardiac insufficiency are being implanted with a ventricular assist device as a bridge to transplant without legal approval for hospital discharge ...
Kathrin Rottermann +7 more
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Trials, 2021 Background Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA ...
Matthew J. Swanson +2 more
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Design and analysis of crossover trials for investigating high-risk medical devices: A review
Contemporary Clinical Trials Communications, 2022 During evaluation of new investigational medical devices, the FDA recommends that investigators design a crossover clinical trial, in which the patients are arranged to cross over from one treatment arm to another. The FDA annually receives the premarket
Bo Zhang, Jing Guo, Hui Zhang
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Development of a Step Counting Algorithm Using the Ambulatory Tibia Load Analysis System for Tibia Fracture Patients [PDF]
, 2018 Introduction: Ambulation can be used to monitor the healing of lower extremity fractures. However, the ambulatory behavior of tibia fracture patients remains unknown due to an inability to continuously quantify ambulation outside of the clinic.
Ackerman, Matt +7 more
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Seeking out non-public information : sell-side analysts and the freedom of information act [PDF]
, 2019 A number of sell-side healthcare analysts gain access to information outside the purview of management through Freedom of Information Act requests to the Food and Drug Administration for records on factory inspections, complaints, and drug and medical ...
Klein, April, Li, Tao, Zhang, Bobo
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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
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Bottlenecks to Clinical Translation of Direct Brain-Computer Interfaces
Frontiers in Systems Neuroscience, 2014 Despite several decades of research into novel brain-implantable devices to treat a range of diseases, only two- cochlear implants for sensorineural hearing loss and deep brain stimulation for movement disorders- have yielded any appreciable clinical ...
Mijail Demian Serruya
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CVIR Endovascular, 2023 Purpose To demonstrate safety and effectiveness of the novel ByCross® atherectomy system for treatment of complex femorodistal > 80% arterial stenosis.
Jörg Tessarek, Ralf Kolvenbach
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Bronchial thermoplasty-an update
Annals of Thoracic Medicine, 2018 Bronchial Thermoplasty is a procedure that involves the delivery of radiofrequency energy during bronchoscopy to airways in order to selectively ablate airway smooth muscles.
Faria Nasim, Vivek N Iyer
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Titanium versus absorbable tacks comparative study (TACS): a multicenter, non-inferiority prospective evaluation during laparoscopic repair of ventral and incisional hernia: study protocol for randomized controlled trial [PDF]
, 2015 BACKGROUND: Laparoscopic repair of ventral and incisional hernias has gained popularity since many studies have reported encouraging results in terms of outcomee and recurrence.
Baldazzi, G +5 more
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