2025
FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program
Kadakia K, Dhruva S, Ross J, Burke J, Johnston J, Ramachandran R, Krumholz H, Rathi V. FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program. JAMA Internal Medicine 2025, 185: 996-1004. PMID: 40587167, PMCID: PMC12210143, DOI: 10.1001/jamainternmed.2025.2235.Peer-Reviewed Original ResearchConceptsFood and Drug AdministrationFDA review timesFood and Drug Administration authorityFood and Drug Administration dataShort follow-up durationUS Food and Drug AdministrationFollow-up durationDevice programmingEffectiveness end pointCross-sectional studyHigh-risk devicesSurrogate measureTarget timeframePostmarketing studiesMain OutcomesEnd pointsPatient accessDrug AdministrationHigh riskClass IStudy characteristicsTherapeutic devicesClinical testingSurrogate measures of effectivenessMeasures of effectiveness
2019
Evaluation of the Patient Request Process for Radiology Imaging in U.S. Hospitals.
Lye CT, Krumholz HM, Eckroate JE, Daniel JG, deBronkart D, Mann MK, Hsiao AL, Forman HP. Evaluation of the Patient Request Process for Radiology Imaging in U.S. Hospitals. Radiology 2019, 292: 409-413. PMID: 31184560, DOI: 10.1148/radiol.2019190473.Peer-Reviewed Original Research
2018
Assessment of US Hospital Compliance With Regulations for Patients’ Requests for Medical Records
Lye CT, Forman HP, Gao R, Daniel JG, Hsiao AL, Mann MK, deBronkart D, Campos HO, Krumholz HM. Assessment of US Hospital Compliance With Regulations for Patients’ Requests for Medical Records. JAMA Network Open 2018, 1: e183014. PMID: 30646219, PMCID: PMC6324595, DOI: 10.1001/jamanetworkopen.2018.3014.Peer-Reviewed Original Research
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