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Medical Imaging Data Strategies for Catalyzing AI Medical Device Innovation.

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Title: Medical Imaging Data Strategies for Catalyzing AI Medical Device Innovation.
Authors: Samala RK; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Ravi.Samala@fda.hhs.gov., Gallas BD; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Zamzmi G; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Juluru K; Digital Health Center of Excellence, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Khan A; Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Bahr C; Digital Health Center of Excellence, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Ochs R; Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Carranza D; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Granstedt J; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Margerrison E; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA., Badano A; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Source: Journal of imaging informatics in medicine [J Imaging Inform Med] 2025 Dec; Vol. 38 (6), pp. 3417-3424. Date of Electronic Publication: 2025 Jan 29.
Publication Type: Journal Article
Journal Info: Publisher: Springer Nature Country of Publication: Switzerland NLM ID: 9918663679206676 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2948-2933 (Electronic) Linking ISSN: 29482925 NLM ISO Abbreviation: J Imaging Inform Med Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Medical Imaging Data Strategies for Catalyzing AI Medical Device Innovation.
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  Data: <searchLink fieldCode="AU" term="%22Samala+RK%22">Samala RK</searchLink>; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Ravi.Samala@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Gallas+BD%22">Gallas BD</searchLink>; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Zamzmi+G%22">Zamzmi G</searchLink>; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Juluru+K%22">Juluru K</searchLink>; Digital Health Center of Excellence, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Khan+A%22">Khan A</searchLink>; Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Bahr+C%22">Bahr C</searchLink>; Digital Health Center of Excellence, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Ochs+R%22">Ochs R</searchLink>; Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Carranza+D%22">Carranza D</searchLink>; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Granstedt+J%22">Granstedt J</searchLink>; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Margerrison+E%22">Margerrison E</searchLink>; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Badano+A%22">Badano A</searchLink>; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
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  Data: <searchLink fieldCode="JN" term="%229918663679206676%22">Journal of imaging informatics in medicine</searchLink> [J Imaging Inform Med] 2025 Dec; Vol. 38 (6), pp. 3417-3424. <i>Date of Electronic Publication: </i>2025 Jan 29.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer+Nature%22">Springer Nature </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>9918663679206676 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2948-2933 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2229482925%22">29482925 </searchLink><i>NLM ISO Abbreviation: </i>J Imaging Inform Med <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s10278-024-01374-6
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              M: 12
              Text: 2025 Dec
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              Y: 2025
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