BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

197 related articles for article (PubMed ID: 36342705)

  • 1. Artificial Intelligence in Breast Cancer Screening: Evaluation of FDA Device Regulation and Future Recommendations.
    Potnis KC; Ross JS; Aneja S; Gross CP; Richman IB
    JAMA Intern Med; 2022 Dec; 182(12):1306-1312. PubMed ID: 36342705
    [TBL] [Abstract][Full Text] [Related]  

  • 2. The 2021 landscape of FDA-approved artificial intelligence/machine learning-enabled medical devices: An analysis of the characteristics and intended use.
    Zhu S; Gilbert M; Chetty I; Siddiqui F
    Int J Med Inform; 2022 Sep; 165():104828. PubMed ID: 35780651
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study.
    Lång K; Josefsson V; Larsson AM; Larsson S; Högberg C; Sartor H; Hofvind S; Andersson I; Rosso A
    Lancet Oncol; 2023 Aug; 24(8):936-944. PubMed ID: 37541274
    [TBL] [Abstract][Full Text] [Related]  

  • 4. FDA Regulation and Approval of Medical Devices: 1976-2020.
    Darrow JJ; Avorn J; Kesselheim AS
    JAMA; 2021 Aug; 326(5):420-432. PubMed ID: 34342614
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review.
    Clark P; Kim J; Aphinyanaphongs Y
    JAMA Netw Open; 2023 Jul; 6(7):e2321792. PubMed ID: 37405771
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions.
    Hernandez-Boussard T; Lundgren MP; Shah N
    J Am Med Inform Assoc; 2021 Jun; 28(6):1353-1355. PubMed ID: 33674865
    [TBL] [Abstract][Full Text] [Related]  

  • 7. 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]  

  • 8. 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]  

  • 9. FDA-regulated AI Algorithms: Trends, Strengths, and Gaps of Validation Studies.
    Ebrahimian S; Kalra MK; Agarwal S; Bizzo BC; Elkholy M; Wald C; Allen B; Dreyer KJ
    Acad Radiol; 2022 Apr; 29(4):559-566. PubMed ID: 34969610
    [TBL] [Abstract][Full Text] [Related]  

  • 10. FDA-approved machine learning algorithms in neuroradiology: A systematic review of the current evidence for approval.
    Yearley AG; Goedmakers CMW; Panahi A; Doucette J; Rana A; Ranganathan K; Smith TR
    Artif Intell Med; 2023 Sep; 143():102607. PubMed ID: 37673576
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Trends in clinical validation and usage of US Food and Drug Administration-cleared artificial intelligence algorithms for medical imaging.
    Khunte M; Chae A; Wang R; Jain R; Sun Y; Sollee JR; Jiao Z; Bai HX
    Clin Radiol; 2023 Feb; 78(2):123-129. PubMed ID: 36625218
    [TBL] [Abstract][Full Text] [Related]  

  • 12. US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016.
    Rathi VK; Gadkaree SK; Ross JS; Kozin ED; Sethi RK; Naunheim MR; Puram SV; Gray ST
    Otolaryngol Head Neck Surg; 2017 Oct; 157(4):608-617. PubMed ID: 28786317
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Artificial intelligence in breast cancer screening: primary care provider preferences.
    Hendrix N; Hauber B; Lee CI; Bansal A; Veenstra DL
    J Am Med Inform Assoc; 2021 Jun; 28(6):1117-1124. PubMed ID: 33367670
    [TBL] [Abstract][Full Text] [Related]  

  • 14. 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]  

  • 15. Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.
    Dubin JR; Simon SD; Norrell K; Perera J; Gowen J; Cil A
    JAMA Netw Open; 2021 May; 4(5):e217274. PubMed ID: 33956132
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Can artificial intelligence replace ultrasound as a complementary tool to mammogram for the diagnosis of the breast cancer?
    Mansour S; Kamal R; Hashem L; AlKalaawy B
    Br J Radiol; 2021 Dec; 94(1128):20210820. PubMed ID: 34613796
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Use of artificial intelligence for image analysis in breast cancer screening programmes: systematic review of test accuracy.
    Freeman K; Geppert J; Stinton C; Todkill D; Johnson S; Clarke A; Taylor-Phillips S
    BMJ; 2021 Sep; 374():n1872. PubMed ID: 34470740
    [TBL] [Abstract][Full Text] [Related]  

  • 18. FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks.
    Muehlematter UJ; Bluethgen C; Vokinger KN
    Lancet Digit Health; 2023 Sep; 5(9):e618-e626. PubMed ID: 37625896
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.
    Chang L; Dhruva SS; Chu J; Bero LA; Redberg RF
    BMJ; 2015 Jun; 350():h2613. PubMed ID: 26063311
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Effect of artificial intelligence-based computer-aided diagnosis on the screening outcomes of digital mammography: a matched cohort study.
    Kim H; Choi JS; Kim K; Ko ES; Ko EY; Han BK
    Eur Radiol; 2023 Oct; 33(10):7186-7198. PubMed ID: 37188881
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.