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Therapeutic Benefit Ratings for FDA Breakthrough-Designated Devices.

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Title: Therapeutic Benefit Ratings for FDA Breakthrough-Designated Devices.
Authors: Kadakia KT; Department of Medicine, Massachusetts General Hospital, Boston., Swoboda CM; The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research (CATALYST), Columbus, Ohio., Moneer O; Department of Medicine, Stanford University, Stanford, California., Dhruva SS; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco.; Section of Cardiology, Department of Medicine, University of California, San Francisco School of Medicine, San Francisco., Ross JS; Section of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut.; Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut., Krumholz HM; Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut., Burke JF; The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research (CATALYST), Columbus, Ohio.; Department of Neurology, The Ohio State University College of Medicine, Columbus., Rathi VK; The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research (CATALYST), Columbus, Ohio.; Department of Otolaryngology-Head & Neck Surgery, The Ohio State University College of Medicine, Columbus.
Source: JAMA surgery [JAMA Surg] 2026 Apr 01; Vol. 161 (4), pp. 433-435.
Publication Type: Journal Article
Journal Info: Publisher: American Medical Association Country of Publication: United States NLM ID: 101589553 Publication Model: Print Cited Medium: Internet ISSN: 2168-6262 (Electronic) Linking ISSN: 21686254 NLM ISO Abbreviation: JAMA Surg Subsets: MEDLINE; In Process
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Kadakia+KT%22">Kadakia KT</searchLink>; Department of Medicine, Massachusetts General Hospital, Boston.<br /><searchLink fieldCode="AU" term="%22Swoboda+CM%22">Swoboda CM</searchLink>; The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research (CATALYST), Columbus, Ohio.<br /><searchLink fieldCode="AU" term="%22Moneer+O%22">Moneer O</searchLink>; Department of Medicine, Stanford University, Stanford, California.<br /><searchLink fieldCode="AU" term="%22Dhruva+SS%22">Dhruva SS</searchLink>; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco.; Section of Cardiology, Department of Medicine, University of California, San Francisco School of Medicine, San Francisco.<br /><searchLink fieldCode="AU" term="%22Ross+JS%22">Ross JS</searchLink>; Section of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut.; Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut.<br /><searchLink fieldCode="AU" term="%22Krumholz+HM%22">Krumholz HM</searchLink>; Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut.<br /><searchLink fieldCode="AU" term="%22Burke+JF%22">Burke JF</searchLink>; The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research (CATALYST), Columbus, Ohio.; Department of Neurology, The Ohio State University College of Medicine, Columbus.<br /><searchLink fieldCode="AU" term="%22Rathi+VK%22">Rathi VK</searchLink>; The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research (CATALYST), Columbus, Ohio.; Department of Otolaryngology-Head & Neck Surgery, The Ohio State University College of Medicine, Columbus.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22American+Medical+Association%22">American Medical Association </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101589553 <i>Publication Model: </i>Print <i>Cited Medium: </i>Internet <i>ISSN: </i>2168-6262 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2221686254%22">21686254 </searchLink><i>NLM ISO Abbreviation: </i>JAMA Surg <i>Subsets: </i>MEDLINE; In Process
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        Value: 10.1001/jamasurg.2025.6859
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              Text: 2026 Apr 01
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