2022
Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersMeSH KeywordsDevice ApprovalEquipment and SuppliesEquipment SafetyHumansProduct Surveillance, PostmarketingRisk FactorsUnited StatesUnited States Food and Drug AdministrationConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
2018
Fulfilling the Promise of Unique Device Identifiers.
Dhruva SS, Ross JS, Schulz WL, Krumholz HM. Fulfilling the Promise of Unique Device Identifiers. Annals Of Internal Medicine 2018, 169: 183-185. PMID: 29868760, DOI: 10.7326/m18-0526.Commentaries, Editorials and Letters
2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
2009
Relationships with the drug industry: More regulation, greater transparency
Krumholz HM, Ross JS. Relationships with the drug industry: More regulation, greater transparency. The BMJ 2009, 338: b211. PMID: 19193612, DOI: 10.1136/bmj.b211.Commentaries, Editorials and Letters