These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

170 related articles for article (PubMed ID: 31997227)

  • 1. A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions.
    Iwaishi C; Iwasaki K
    Ther Innov Regul Sci; 2020 Jul; 54(4):953-963. PubMed ID: 31997227
    [TBL] [Abstract][Full Text] [Related]  

  • 2. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
    Samuel AM; Rathi VK; Grauer JN; Ross JS
    Clin Orthop Relat Res; 2016 Apr; 474(4):1053-68. PubMed ID: 26584802
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
    Rathi VK; Krumholz HM; Masoudi FA; Ross JS
    JAMA; 2015 Aug; 314(6):604-12. PubMed ID: 26262798
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.
    Walter JR; Hayman E; Tsai S; Ghobadi CW; Xu S
    Obstet Gynecol; 2016 Jun; 127(6):1110-1117. PubMed ID: 27159747
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.
    Gopal AD; Rathi VK; Teng CC; Del Priore L; Ross JS
    Ophthalmology; 2017 Aug; 124(8):1237-1246. PubMed ID: 28501378
    [TBL] [Abstract][Full Text] [Related]  

  • 6. [United States Medical Device Postmarket Surveillance System Operational Experience and Learning].
    Zhu S; Xu X
    Zhongguo Yi Liao Qi Xie Za Zhi; 2017 Mar; 41(2):123-126. PubMed ID: 29862685
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration.
    Rathi VK; Ross JS; Samuel AM; Mehra S
    Otolaryngol Head Neck Surg; 2015 Sep; 153(3):400-8. PubMed ID: 26044785
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra.
    Kadakia KT; Beckman AL; Ross JS; Krumholz HM
    JAMA Intern Med; 2022 Jan; 182(1):59-65. PubMed ID: 34842892
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.
    Downing NS; Shah ND; Aminawung JA; Pease AM; Zeitoun JD; Krumholz HM; Ross JS
    JAMA; 2017 May; 317(18):1854-1863. PubMed ID: 28492899
    [TBL] [Abstract][Full Text] [Related]  

  • 10. An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
    Peña C; Bowsher K; Costello A; De Luca R; Doll S; Li K; Schroeder M; Stevens T
    IEEE Trans Neural Syst Rehabil Eng; 2007 Sep; 15(3):421-4. PubMed ID: 17894274
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy.
    Scott B
    Food Drug Law J; 2011; 66(3):377-404, ii. PubMed ID: 24505854
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Assessment of Data Sources That Support US Food and Drug Administration Medical Devices Safety Communications.
    Tau N; Shepshelovich D
    JAMA Intern Med; 2020 Nov; 180(11):1420-1426. PubMed ID: 32986074
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Postmarket evaluation of breakthrough technologies.
    Rao SV; Califf RM; Kramer JM; Peterson ED; Gross TP; Pepine CJ; Williams DO; Donohoe D; Waksman R; Mehran R; Krucoff MW
    Am Heart J; 2008 Aug; 156(2):201-8. PubMed ID: 18657647
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011.
    Rathi VK; Krumholz HM; Masoudi FA; Ross JS
    JAMA Netw Open; 2020 Aug; 3(8):e2014496. PubMed ID: 32857145
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.
    Reynolds IS; Rising JP; Coukell AJ; Paulson KH; Redberg RF
    JAMA Intern Med; 2014 Nov; 174(11):1773-9. PubMed ID: 25265209
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad.
    Selzman KA; Patel H; Cavanaugh K
    J Interv Card Electrophysiol; 2019 Nov; 56(2):173-182. PubMed ID: 31418099
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015.
    Connor MJ; Marshall DC; Moiseenko V; Moore K; Cervino L; Atwood T; Sanghvi P; Mundt AJ; Pawlicki T; Recht A; Hattangadi-Gluth JA
    Int J Radiat Oncol Biol Phys; 2017 Jan; 97(1):18-26. PubMed ID: 27979446
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Descriptive analysis of postmarket surveillance data for hip implants.
    Pane J; Verhamme KMC; Rebollo I; Sturkenboom MCJM
    Pharmacoepidemiol Drug Saf; 2020 Apr; 29(4):380-387. PubMed ID: 32128913
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Medical device regulation: an introduction for the practicing physician.
    Maisel WH
    Ann Intern Med; 2004 Feb; 140(4):296-302. PubMed ID: 14970153
    [TBL] [Abstract][Full Text] [Related]  

  • 20. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics.
    Eadie A; MacGregor A; Wallach J; Ross J; Herder M
    BMJ Evid Based Med; 2023 Jun; 28(3):151-156. PubMed ID: 36944478
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.