{
  "abstract": "This cross-sectional study investigated characteristics and reporting of updates to artificial intelligence (AI)/machine learning–based medical devices cleared through the Food and Drug Administration (FDA) 501(k) pathway.",
  "abstract_shown": true,
  "affiliations": [
    "Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France",
    "Centre d’Epidémiologie Clinique, Assistance Publique–Hôpitaux de Paris, Hôpital Hôtel Dieu, Paris, France",
    "Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City, New York"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 4,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Maria Zogka"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Melissa Amyx"
    },
    {
      "affs": [
        0,
        1,
        2
      ],
      "name": "Philippe Ravaud"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Viet-Thi Tran"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9d173nyzqx0xa.bib",
  "cited_by": 0,
  "doi": "10.1001/jamanetworkopen.2026.41071",
  "fulltext_url": null,
  "id": "9d173nyzqx0xa",
  "issns": [
    "2574-3805"
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  "landing_url": "https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2856263",
  "language": null,
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [],
  "openalex": null,
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-11-05",
  "publisher": "American Medical Association (AMA)",
  "ris": "https://research.draconitic.com/paper/9d173nyzqx0xa.ris",
  "sources": [
    {
      "first_seen": "2026-11-06T00:21:22Z",
      "native_id": "10.1001/jamanetworkopen.2026.41071",
      "source": "crossref",
      "url": "https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2856263"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "issn:2574-3805",
      "subfield": "general"
    }
  ],
  "title": "Updated AI and/or Machine Learning–Based Medical Devices Cleared Through the FDA 510(k) Pathway",
  "title_text": "Updated AI and/or Machine Learning–Based Medical Devices Cleared Through the FDA 510(k) Pathway",
  "type": "peer-reviewed",
  "updated_at": "2026-11-07T00:21:20Z",
  "url": "https://research.draconitic.com/paper/9d173nyzqx0xa",
  "venue": "JAMA Network Open",
  "versions": []
}