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
2024
Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.
Kadakia K, Bikdeli B, Gupta A, Dhruva S, Ross J, Krumholz H. Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals Of Internal Medicine 2024, 177: 1711-1718. PMID: 39556835, DOI: 10.7326/annals-24-00089.Peer-Reviewed Original ResearchMedical device regulationDetect adverse eventsDevice regulationInferior vena cavaPatient safetyFood and Drug AdministrationDevice safetyOutcome definitionsStudy protocolPatient deathClinical study protocolAdverse eventsProfessional societiesCourt documentsClinical practiceRegulatory reformCliniciansInferior vena cava perforationDevice labelingPrevention of pulmonary embolismPublished literaturePublic recordsInaccurate informationCelect IVC filtersMedical devicesModernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
Kadakia K, Rathi V, Dhruva S, Ross J, Krumholz H. Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process. Annals Of Internal Medicine 2024, 177: 1558-1565. PMID: 39374526, DOI: 10.7326/annals-24-00728.Peer-Reviewed Original ResearchClass I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024, 177: 1499-1508. PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketingFibrinolytic Agents in Thromboembolic Diseases: Historical Perspectives and Approved Indications
Rashedi S, Greason C, Sadeghipour P, Talasaz A, O'Donoghue M, Jimenez D, Monreal M, Anderson C, Elkind M, Kreuziger L, Lang I, Goldhaber S, Konstantinides S, Piazza G, Krumholz H, Braunwald E, Bikdeli B. Fibrinolytic Agents in Thromboembolic Diseases: Historical Perspectives and Approved Indications. Seminars In Thrombosis And Hemostasis 2024, 50: 773-789. PMID: 38428841, DOI: 10.1055/s-0044-1781451.Peer-Reviewed Original ResearchST-segment elevation myocardial infarctionTissue plasminogen activatorFood and Drug AdministrationFibrinolytic agentsThromboembolic diseasePlasminogen activatorFood and Drug Administration approvalArterial thromboembolic eventsElevation myocardial infarctionCentral venous access device occlusionPlasma half-lifeU.S. Food and Drug AdministrationAcute ischemic strokePulmonary embolismThromboembolic eventsHemodynamic compromiseDevice occlusionTreated patientsRecanalize occluded vesselsActive protease plasminDrug AdministrationMyocardial infarctionApproved indicationsOccluded vesselIschemic stroke
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