Concepedia

Premarket Approval

Premarket Approval is a regulatory review process, distinct from other forms of market authorization, that requires a medical device manufacturer to demonstrate the safety and effectiveness of a high-risk device to a regulatory authority before it can be marketed.

100

Publications

6.1K

Citations

350

Authors

183

Institutions

Publications per year

2017–2026

36

Parents

Publications

100

The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

Stan Benjamens, Pranavsingh Dhunnoo, Bertalan Meskó · npj Digital Medicine · 2020 · 1.1K citations · Full text

, , +9

Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: Review of registry of complications and recommendations to minimize future risk

Ziyad M. Hijazi, John L. Bass, John P. Cheatham et al. · Catheterization and Cardiovascular Interventions · 2004 · 514 citations

, , +16

Erosion of Amplatzer Septal Occluder Device After Closure of Secundum Atrial Septal Defects: Review of Registry of Complications and Recommendations to Minimize Future Risk

T.P. Graham · Yearbook of Cardiology · 2006 · 404 citations

, , +16

Medical Device Recalls and the FDA Approval Process

Diana M. Zuckerman, P.J. Brown, Steven E. Nissen · Archives of Internal Medicine · 2011 · 259 citations

, , +16

Regulatory Oversight and Safety of Probiotic Use

Veena Venugopalan, Kimberly Shriner, Annie Wong‐Beringer · Emerging infectious diseases · 2010 · 213 citations · Full text

, , +13

1–5 of 100

Authors

350

  1. JS
    Joseph S. Ross

    Yale University, United States

    8 publications · 302 citations

    8

    h-index

  2. RF
    Rita F. Redberg

    University of California, San Francisco, United States

    8 publications · 226 citations

    8

    h-index

  3. VK
    Vinay K. Rathi

    Massachusetts Eye and Ear Infirmary, United States

    6 publications · 221 citations

    6

    h-index

  4. SS
    Sanket S. Dhruva

    University of California, San Francisco, United States

    5 publications · 121 citations

    5

    h-index

  5. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    5 publications · 351 citations

    5

    h-index

1–5 of 350

Institutions

183

  1. Harvard University

    Cambridge, United States

    12 h-index

    22 publications

    1.2K citations

  2. Center for Devices and Radiological Health

    Rockville, United States

    10 h-index

    37 publications

    1.7K citations

  3. University of California, San Francisco

    San Francisco, United States

    9 h-index

    14 publications

    484 citations

  4. Yale University

    New Haven, United States

    8 h-index

    21 publications

    828 citations

  5. United States Food and Drug Administration

    Silver Spring, United States

    6 h-index

    18 publications

    935 citations

  6. Yale New Haven Hospital

    New Haven, United States

    5 h-index

    10 publications

    447 citations

  7. Brigham and Women's Hospital

    Boston, United States

    5 h-index

    11 publications

    944 citations

  8. Beth Israel Deaconess Medical Center

    Boston, United States

    4 h-index

    5 publications

    207 citations

1–8 of 183

Venues

  1. PubMed

    Repository · 8 publications · 197 citations

    7

    h-index

  2. JAMA

    7 publications · 477 citations

    7

    h-index

  3. Plastic & Reconstructive Surgery

    6 publications · 444 citations

    6

    h-index

  4. JAMA Internal Medicine

    5 publications · 139 citations

    5

    h-index

  5. ASAIO Journal

    3 publications · 51 citations

    3

    h-index

1–5