9 results match your criteria: "From the Center for Devices and Radiological Health[Affiliation]"
US Backscatter for Liver Fat Quantification: An AIUM-RSNA QIBA Pulse-Echo Quantitative Ultrasound Initiative.
Radiology
December 2022
From the Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, WO62, Room 2114, Silver Spring, MD 20993 (K.A.W.); Bioacoustics Research Laboratory, Department of Electrical and Computer Engineering, University of Illinois at Urbana-Champaign, Urbana, Ill (A.H.); Department of Radiology, University of Michigan, Ann Arbor, Mich (J.M.R.); Ultrasound Research and Education, Rocky Vista University, Ivins, Utah (J.G.); Department of Engineering, Pontificia Universidad Católica del Perú, Lima, Peru (R.L.); Laboratory of Biorheology and Medical Ultrasonics, University of Montreal Hospital Research Center, Montreal, Canada (G.C.); Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Division of Radiotherapy and Imaging, Joint Department of Physics, London, UK (J.B.); and Pfizer, Cambridge, Mass (T.T.).
Nonalcoholic fatty liver disease (NAFLD) is believed to affect one-third of American adults. Noninvasive methods that enable detection and monitoring of NAFLD have the potential for great public health benefits. Because of its low cost, portability, and noninvasiveness, US is an attractive alternative to both biopsy and MRI in the assessment of liver steatosis.
View Article and Find Full Text PDFDrug-Coated Devices for Peripheral Arterial Disease.
N Engl J Med
January 2021
From the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
Blood passage through medical devices can cause hemolysis and increased levels of plasma free hemoglobin (pfH) that may lead to adverse effects such as vasoconstriction and renal tubule injury. Although the hemolytic potential of devices is typically characterized in vitro using animal blood, the results can be impacted by various blood parameters, such as donor species. Moreover, it is unclear how to relate measured in vitro hemolysis levels to clinical performance because pfH accumulation in vivo depends on both hemolysis rate and availability of plasma haptoglobin (Hpt) that can bind and safely eliminate pfH.
View Article and Find Full Text PDFPatent Foramen Ovale after Cryptogenic Stroke - Assessing the Evidence for Closure.
N Engl J Med
September 2017
From the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.
N Engl J Med
April 2017
From the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
FDA Benchmark Medical Device Flow Models for CFD Validation.
ASAIO J
January 2018
From the *Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Food and Drug Administration, Silver Spring, Maryland; †Department of Biomedical Engineering, Rochester Institute of Technology, Rochester, New York; ‡Department of Cardiovascular Engineering, RWTH Aachen University, Aachen, Germany; and §Department of Biomedical Engineering, Pennsylvania State University, University Park, Pennsylvania.
Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.
View Article and Find Full Text PDFReduced Leaflet Motion in Bioprosthetic Aortic Valves--The FDA Perspective.
N Engl J Med
November 2015
From the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
A strategically aligned Food and Drug Administration: New ways to leverage research and deliver safe, effective, and secure devices for trauma care.
J Trauma Acute Care Surg
October 2015
From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Cardiac resynchronization therapy in women versus men: observational comparative effectiveness study from the National Cardiovascular Data Registry.
Circ Cardiovasc Qual Outcomes
March 2015
From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).
Background: Women have been under-represented in trials of cardiac resynchronization therapy-defibrillators (CRT-D). Previous studies suggest that women benefit from CRT-D at shorter QRS duration than men and that there may be no benefit of CRT-D in patients without left bundle branch block (LBBB) regardless of patient sex.
Methods And Results: We compared sex-specific death risk in 75 079 patients with New York Heart Association class III or IV heart failure, reduced left ventricular ejection fraction, and prolonged QRS duration (≥120 ms) receiving either CRT-D or implantable cardioverter defibrillator in subgroups according to QRS morphology and 10-ms increments in QRS duration.