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Volumn 349, Issue , 2014, Pages

Regulating incremental innovation in medical devices

Author keywords

[No Author keywords available]

Indexed keywords

CARDIAC IMPLANT; CARDIAC IMPLANTABLE ELECTRONIC DEVICE; COMPARATIVE EFFECTIVENESS; CONSUMER ATTITUDE; DEVICE APPROVAL; DEVICE SAFETY; EDITORIAL; EVIDENCE BASED MEDICINE; HIP PROSTHESIS; HUMAN; KNEE PROSTHESIS; MEDICAL DEVICE REGULATION; METAL ON METAL JOINT PROSTHESIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; SURVIVAL RATE; TREATMENT OUTCOME; FEMALE; MALE; NOTE; STANDARD;

EID: 84988813583     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.g5303     Document Type: Editorial
Times cited : (11)

References (11)
  • 1
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    • FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012
    • Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. JAMA 2014;311:385-91.
    • (2014) JAMA , vol.311 , pp. 385-391
    • Rome, B.N.1    Kramer, D.B.2    Kesselheim, A.S.3
  • 2
    • 84988892551 scopus 로고    scopus 로고
    • Appraisal of evidence base for introduction of new implants in hip and knee replacement: A systematic review of five widely used device technologies
    • Nieuwenhuijse MJ, Nelissen RGHH, Schoones JW, Marinac-Dabic D, Sedrakyan A. Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies. BMJ 2014;349:g5133.
    • (2014) BMJ , vol.349 , pp. g5133
    • Nieuwenhuijse, M.J.1    Nelissen, R.G.H.H.2    Schoones, J.W.3    Marinac-Dabic, D.4    Sedrakyan, A.5
  • 4
    • 84857885489 scopus 로고    scopus 로고
    • Regulation of medical devices in the United States and European Union
    • Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med 2012;366:848-55.
    • (2012) N Engl J Med , vol.366 , pp. 848-855
    • Kramer, D.B.1    Xu, S.2    Kesselheim, A.S.3
  • 5
    • 79956305129 scopus 로고    scopus 로고
    • Europeans are left to their own devices
    • Cohen D, Billingsley M. Europeans are left to their own devices. BMJ 2011;342:d2748.
    • (2011) BMJ , vol.342 , pp. d2748
    • Cohen, D.1    Billingsley, M.2
  • 6
    • 84872082045 scopus 로고    scopus 로고
    • The 510 (k) ancestry of a metal-on-metal hip implant
    • Ardaugh BM, Graves SE, Redberg RF. The 510 (k) ancestry of a metal-on-metal hip implant. N Engl J Med 2013;368:97-100.
    • (2013) N Engl J Med , vol.368 , pp. 97-100
    • Ardaugh, B.M.1    Graves, S.E.2    Redberg, R.F.3
  • 8
    • 84890936816 scopus 로고    scopus 로고
    • Primary hip replacement prostheses and their evidence base: Systematic review of literature
    • Kynaston-Pearson F, Ashmore AM, Malak TT, Rombach I, Taylor A, Beard D, et al. Primary hip replacement prostheses and their evidence base: systematic review of literature. BMJ 2013;347:f6956.
    • (2013) BMJ , vol.347 , pp. f6956
    • Kynaston-Pearson, F.1    Ashmore, A.M.2    Malak, T.T.3    Rombach, I.4    Taylor, A.5    Beard, D.6
  • 9
    • 65349165683 scopus 로고    scopus 로고
    • Using a drug facts box to communicate drug benefits and harms: Two randomized trials
    • Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med 2009;150:516-27.
    • (2009) Ann Intern Med , vol.150 , pp. 516-527
    • Schwartz, L.M.1    Woloshin, S.2    Welch, H.G.3
  • 11
    • 84895793436 scopus 로고    scopus 로고
    • Improving medical device regulation: The United States and Europe in perspective
    • Sorenson C, Drummond M. Improving medical device regulation: the United States and Europe in perspective. Milbank Q 2014;92:114-50.
    • (2014) Milbank Q , vol.92 , pp. 114-150
    • Sorenson, C.1    Drummond, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.