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Wyszukujesz frazę ""Device Approval"" wg kryterium: Temat


Tytuł :
Key Principles of Clinical Validation, Device Approval, and Insurance Coverage Decisions of Artificial Intelligence.
Autorzy :
Park SH; Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. .
Choi J; Department of Biomedical Engineering, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Byeon JS; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
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Źródło :
Korean journal of radiology [Korean J Radiol] 2021 Mar; Vol. 22 (3), pp. 442-453.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Review
MeSH Terms :
Artificial Intelligence*
Device Approval*
Insurance Coverage*
Area Under Curve ; Case-Control Studies ; Decision Making ; Delivery of Health Care ; Humans ; Lung Neoplasms/diagnosis ; ROC Curve
Czasopismo naukowe
Tytuł :
How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals.
Autorzy :
Wu E; Department of Electrical Engineering, Stanford University, Stanford, CA, USA.
Wu K; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.
Daneshjou R; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.; Department of Dermatology, Stanford University, Stanford, CA, USA.
Ouyang D; Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Ho DE; Stanford Law School, Stanford University, Stanford, CA, USA.
Zou J; Department of Electrical Engineering, Stanford University, Stanford, CA, USA. .; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA. .; Chan-Zuckerberg Biohub, San Francisco, CA, USA. .
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Źródło :
Nature medicine [Nat Med] 2021 Apr; Vol. 27 (4), pp. 582-584.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
MeSH Terms :
Artificial Intelligence*
Device Approval*
Equipment and Supplies*
United States Food and Drug Administration*
Algorithms ; Databases as Topic ; Humans ; United States
Czasopismo naukowe
Tytuł :
COVID-19: Pay attention to unverified devices.
Autorzy :
Saito T; Department of Anesthesiology, Saitama Medical Center, Dokkyo Medical University, Koshigaya, Japan - .
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Źródło :
Minerva anestesiologica [Minerva Anestesiol] 2021 Apr; Vol. 87 (4), pp. 491-492. Date of Electronic Publication: 2020 Dec 10.
Typ publikacji :
Journal Article
MeSH Terms :
COVID-19*
Device Approval*
Pandemics*
Equipment and Supplies/*adverse effects
Humans
Czasopismo naukowe
Tytuł :
Medicare's New Device-Coverage Pathway - Breakthrough or Breakdown?
Autorzy :
Rathi VK; From the Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston (V.K.R.); the Section of General Medicine (J.S.R.), Yale School of Medicine (J.L.J.), New Haven, CT; and the Department of Medicine, University of California, San Francisco, School of Medicine, San Francisco (S.S.D.).
Johnston JL; From the Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston (V.K.R.); the Section of General Medicine (J.S.R.), Yale School of Medicine (J.L.J.), New Haven, CT; and the Department of Medicine, University of California, San Francisco, School of Medicine, San Francisco (S.S.D.).
Ross JS; From the Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston (V.K.R.); the Section of General Medicine (J.S.R.), Yale School of Medicine (J.L.J.), New Haven, CT; and the Department of Medicine, University of California, San Francisco, School of Medicine, San Francisco (S.S.D.).
Dhruva SS; From the Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston (V.K.R.); the Section of General Medicine (J.S.R.), Yale School of Medicine (J.L.J.), New Haven, CT; and the Department of Medicine, University of California, San Francisco, School of Medicine, San Francisco (S.S.D.).
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Źródło :
The New England journal of medicine [N Engl J Med] 2021 Mar 25; Vol. 384 (12), pp. e43. Date of Electronic Publication: 2021 Mar 10.
Typ publikacji :
Journal Article
MeSH Terms :
Government Regulation*
Insurance Coverage*/economics
Insurance Coverage*/legislation & jurisprudence
Medicare*
Device Approval/*legislation & jurisprudence
Equipment and Supplies/*economics
Centers for Medicare and Medicaid Services, U.S. ; Device Approval/standards ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Public Speaker Characteristics at Meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel.
Autorzy :
Khattab MH; Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA. Electronic address: .
Weaver M; Kansas City University of Medicine and Biosciences, Kansas City, Missouri, USA.
Cook C; Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.
Kinder N; Kansas City University of Medicine and Biosciences, Kansas City, Missouri, USA.
Vassar M; Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.
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Źródło :
American journal of ophthalmology [Am J Ophthalmol] 2021 Mar; Vol. 223, pp. 28-32. Date of Electronic Publication: 2020 Nov 06.
Typ publikacji :
Journal Article
MeSH Terms :
Conflict of Interest*
Device Approval*
Advisory Committees/*ethics
Dermatology/*organization & administration
Drug Evaluation/*ethics
Ophthalmology/*organization & administration
United States Food and Drug Administration/*ethics
Congresses as Topic ; Cross-Sectional Studies ; Humans ; United States
Czasopismo naukowe
Tytuł :
Mandatory Registration and Results Reporting of Real-World Evidence Studies of FDA-Regulated Medical Products.
Autorzy :
Dhruva SS; Department of Medicine, San Francisco Veterans Affairs Health Care System, and University of California, San Francisco, School of Medicine. Electronic address: .
Shah ND; Division of Health Care Policy and Research and Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN.
Ross JS; Section of General Internal Medicine and National Clinician Scholars Program, Yale School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT.
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Źródło :
Mayo Clinic proceedings [Mayo Clin Proc] 2020 Dec; Vol. 95 (12), pp. 2609-2611. Date of Electronic Publication: 2020 Oct 21.
Typ publikacji :
Journal Article
MeSH Terms :
Device Approval*/legislation & jurisprudence
Device Approval*/standards
Mandatory Reporting*
Product Surveillance, Postmarketing*/methods
Product Surveillance, Postmarketing*/standards
Access to Information ; Clinical Decision-Making ; Humans ; Public Reporting of Healthcare Data ; Registries/standards ; Risk Assessment ; United States
Czasopismo naukowe
Tytuł :
Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities.
Autorzy :
Bolislis WR; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
de Lucia ML; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Dolz F; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Mo R; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Nagaoka M; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Rodriguez H; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Woon ML; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Yu W; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Kühler TC; Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France. Electronic address: .
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Źródło :
Clinical therapeutics [Clin Ther] 2021 Jan; Vol. 43 (1), pp. 124-139. Date of Electronic Publication: 2020 Nov 30.
Typ publikacji :
Journal Article; Review
MeSH Terms :
COVID-19*
Communication*
Device Approval*
Drug Approval*
Public Policy*
Public-Private Sector Partnerships*
Compassionate Use Trials ; Drug and Narcotic Control ; Health Policy ; Humans ; Medical Device Legislation ; Pandemics ; SARS-CoV-2 ; Time Factors
Czasopismo naukowe
Tytuł :
Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.
Autorzy :
Holmes DR Jr; Mayo Clinic, Rochester, Minnesota. Electronic address: .
Farb AA; U.S. Food and Drug Administration, Silver Spring, Maryland.
Chip Hance R; Regatta Medical, Bannockburn, Illinois.
Leon MB; Department of Medicine, Division of Cardiology, Columbia University Medical Center and Center for Interventional Vascular Therapy, Columbia University, New York, New York.
Goldberg P; Medical Device Innovation Consortium, Arlington, Virginia.
Zuckerman BD; U.S. Food and Drug Administration, Silver Spring, Maryland.
Kaplan AV; Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Rincon-Gonzalez L; Medical Device Innovation Consortium, Arlington, Virginia.
Hunt J; Medical Device Innovation Consortium, Arlington, Virginia.
Walkowiak J; Baylor Scott and White Health, Dallas, Texas.
Mack MJ; Department of Cardiovascular Surgery, Baylor Health Care System, and Baylor Scott and White-The Heart Hospital-Plano Research Center, Plano, Texas.
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Źródło :
Journal of the American College of Cardiology [J Am Coll Cardiol] 2020 Dec 08; Vol. 76 (23), pp. 2786-2794.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Device Approval*
Heart-Assist Devices*
Feasibility Studies ; Humans ; United States
Czasopismo naukowe
Tytuł :
[Preliminary Review of Relationship between Medical Device Evaluation and Quality Management System in Premarket Approval].
Autorzy :
Li Y; Center for Medical Device Evaluation of NMPA, Beijing, 100081.
Zhang Q; Center for Medical Device Evaluation of NMPA, Beijing, 100081.
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Źródło :
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation [Zhongguo Yi Liao Qi Xie Za Zhi] 2020 Dec 08; Vol. 44 (6), pp. 532-536.
Typ publikacji :
Journal Article
MeSH Terms :
Device Approval*
Equipment Safety*
Research Design*
Czasopismo naukowe
Tytuł :
Regulatory Approval and Practice Guidelines Involving Cardiovascular Valve Devices: Determining the Right Evidentiary Bar.
Autorzy :
Mack MJ; Baylor Scott & White Health, Dallas, Texas. Electronic address: .
Adams DH; Mount Sinai Health System, New York, New York.
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Źródło :
Journal of the American College of Cardiology [J Am Coll Cardiol] 2020 Aug 25; Vol. 76 (8), pp. 992-995.
Typ publikacji :
Editorial
MeSH Terms :
Device Approval*
Heart Valve Prosthesis/*standards
Heart Valve Prosthesis Implantation/*instrumentation
Randomized Controlled Trials as Topic/*methods
Research Design/*standards
Equipment Safety/methods ; Humans ; Medical Device Legislation
Opinia redakcyjna
Tytuł :
A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior.
Autorzy :
Ota N; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan.
Tachibana K; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan.
Kusakabe T; Graduate School of Medicine, Osaka City University, Osaka, Japan.
Sanada S; Graduate School of Medicine, Osaka City University, Osaka, Japan.
Kondoh M; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan.
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Źródło :
Clinical and translational science [Clin Transl Sci] 2020 Sep; Vol. 13 (5), pp. 877-879. Date of Electronic Publication: 2020 Apr 03.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Device Approval*
Artificial Intelligence/*legislation & jurisprudence
Equipment and Supplies/*adverse effects
Internet of Things/*legislation & jurisprudence
Inventions/*legislation & jurisprudence
Humans ; Japan
Czasopismo naukowe
Tytuł :
The FDA De Novo medical device pathway, patents and anticompetition.
Autorzy :
Sherkow JS; College of Law, University of Illinois at Urbana-Champaign, Champaign, IL, USA. .; Carl R. Woese Institute for Genomic Biology, University of Illinois at Urbana-Champaign, Champaign, IL, USA. .; Center for Advanced Studies in Biomedical Innovation Law, University of Copenhagen Faculty of Law, Copenhagen, Denmark. .
Aboy M; Centre for Law Medicine and Life Sciences, University of Cambridge, Cambridge, UK. .; Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, MA, USA. .
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Źródło :
Nature biotechnology [Nat Biotechnol] 2020 Sep; Vol. 38 (9), pp. 1028-1029.
Typ publikacji :
Journal Article
MeSH Terms :
Device Approval/*legislation & jurisprudence
Patents as Topic/*legislation & jurisprudence
Device Approval/standards ; Guidelines as Topic ; Humans ; Licensure/legislation & jurisprudence ; Licensure/standards ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Green light for deep brain stimulator incorporating neurofeedback.
Autorzy :
Waltz E; Nashville, TN, USA.
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Źródło :
Nature biotechnology [Nat Biotechnol] 2020 Sep; Vol. 38 (9), pp. 1014-1015.
Typ publikacji :
Wiadomości
MeSH Terms :
Device Approval*
Neurofeedback*
Deep Brain Stimulation/*instrumentation
Electroencephalography/*instrumentation
Nervous System Diseases/*therapy
Brain/physiology ; Brain Waves/physiology ; Deep Brain Stimulation/methods ; Electroencephalography/methods ; Humans ; Nerve Net/physiology
Periodyk
Tytuł :
The IDEAL framework for ensuring safety and effectiveness of medical devices.
Autorzy :
McCulloch P; Nuffield Department of Surgical Science, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU, UK.
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Źródło :
BMJ (Clinical research ed.) [BMJ] 2020 Aug 13; Vol. 370, pp. m3183. Date of Electronic Publication: 2020 Aug 13.
Typ publikacji :
Letter; Comment
MeSH Terms :
Device Approval*
Equipment Safety
Opinia redakcyjna
Tytuł :
Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011.
Autorzy :
Rathi VK; Department of Otolaryngology, Massachusetts Eye and Ear, Boston.
Krumholz HM; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.; Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut.; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
Masoudi FA; Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora.; Colorado Cardiovascular Outcomes Research Consortium, Denver.
Ross JS; Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut.; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.; Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
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Źródło :
JAMA network open [JAMA Netw Open] 2020 Aug 03; Vol. 3 (8), pp. e2014496. Date of Electronic Publication: 2020 Aug 03.
Typ publikacji :
Journal Article
MeSH Terms :
Device Approval*
Prostheses and Implants*
Clinical Trials as Topic/*statistics & numerical data
Product Surveillance, Postmarketing/*statistics & numerical data
Cross-Sectional Studies ; Humans ; Medical Device Legislation ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Regulation Without Representation: Cardiac Device Patient Knowledge and Attitudes About the FDA Regulatory Process.
Autorzy :
Zeitler EP; Geisel School of Medicine at Dartmouth, Hanover, NH & Dartmouth-Hitchcock Medical Center, Lebanon, NH (E.P.Z.).
Al-Khatib SM; Duke Clinical Research Institute, Durham, NC (S.M.A.-K.).; Duke University Hospital, Durham, NC (S.M.A.-K., R.Y.).
Yapejian R; Duke University Hospital, Durham, NC (S.M.A.-K., R.Y.).
Tripp CC; East Carolina University, Departments of Psychology and of Cardiovascular Sciences, Greenville, NC (C.C.T., S.F.S.).
Sears SF; East Carolina University, Departments of Psychology and of Cardiovascular Sciences, Greenville, NC (C.C.T., S.F.S.).
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Źródło :
Circulation. Arrhythmia and electrophysiology [Circ Arrhythm Electrophysiol] 2020 Aug; Vol. 13 (8), pp. e008561. Date of Electronic Publication: 2020 Jul 06.
Typ publikacji :
Letter
MeSH Terms :
Defibrillators, Implantable*
Device Approval*
Health Knowledge, Attitudes, Practice*
Pacemaker, Artificial*
Patient Education as Topic*
United States Food and Drug Administration*
Aged ; Aged, 80 and over ; Female ; Health Care Surveys ; Humans ; Male ; Middle Aged ; Prosthesis Design ; Prosthesis Failure ; United States
Opinia redakcyjna
Tytuł :
Early experience with the FDA's Breakthrough Devices program.
Autorzy :
Johnston JL; Yale University School of Medicine, New Haven, CT, USA.
Dhruva SS; San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.; Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Ross JS; Center for Outcomes Research and Evaluation (CORE), Yale-New Haven Hospital, New Haven, CT, USA.; Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA.; Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
Rathi VK; Department of Otolaryngology - Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston, MA, USA. .
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Źródło :
Nature biotechnology [Nat Biotechnol] 2020 Aug; Vol. 38 (8), pp. 933-938.
Typ publikacji :
Letter; Research Support, N.I.H., Extramural
MeSH Terms :
Device Approval*/legislation & jurisprudence
Equipment and Supplies*
Medical Device Legislation*
United States Food and Drug Administration/*legislation & jurisprudence
Humans ; Product Surveillance, Postmarketing ; United States
Raport
Tytuł :
Enhanced Drug and Device Development by Targeting "Relief of Dyspnea".
Autorzy :
Mahler DA; Geisel School of Medicine at Dartmouth, Hanover, and the Valley Regional Hospital, Claremont, NH. Electronic address: .
Sethi S; Jacobs School of Medicine, University at Buffalo, State University of New York, Buffalo, NY.
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Źródło :
Chest [Chest] 2020 Aug; Vol. 158 (2), pp. 464-466. Date of Electronic Publication: 2020 Jun 30.
Typ publikacji :
Editorial
MeSH Terms :
Device Approval*
Drug Approval*
Outcome Assessment, Health Care*
Dyspnea/*prevention & control
Humans ; United States
Opinia redakcyjna
Tytuł :
Impact of Health Care Reform on Technology and Innovation.
Autorzy :
Kesavan P; Office of Medical Student Research, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8077, St. Louis, MO 63110, USA.
Dy CJ; Department of Orthopaedic Surgery, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8233, St Louis, MO 63110, USA. Electronic address: .
Pokaż więcej
Źródło :
Hand clinics [Hand Clin] 2020 May; Vol. 36 (2), pp. 255-262.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Review
MeSH Terms :
Device Approval*/legislation & jurisprudence
Device Approval*/standards
Equipment and Supplies*/economics
Health Care Reform*
Orthopedics*
Comparative Effectiveness Research ; Consumer Product Safety/legislation & jurisprudence ; Equipment Design ; Government Regulation ; Industry/legislation & jurisprudence ; Industry/statistics & numerical data ; Inventions ; Medical Device Legislation ; Taxes ; United States ; United States Food and Drug Administration
Czasopismo naukowe

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