2015
Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration
Rathi VK, Ross JS, Samuel AM, Mehra S. Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration. Otolaryngology 2015, 153: 400-408. PMID: 26044785, DOI: 10.1177/0194599815587508.Peer-Reviewed Original ResearchConceptsClinical dataUS FoodDrug AdministrationPMA pathwayRetrospective cohort studyAdditional clinical dataPremarket approval pathwaySignificant clinical implicationsCohort studyHigh-risk medical devicesMedian numberClinical implicationsMarketing clearanceLife spanAdministrationSubstantial numberPMA applicationApproval pathwaySupplementsFDATherapeutic devicesPathway
2013
Trends and clinical implications of preoperative breast MRI in Medicare beneficiaries with breast cancer
Killelea BK, Long JB, Chagpar AB, Ma X, Soulos PR, Ross JS, Gross CP. Trends and clinical implications of preoperative breast MRI in Medicare beneficiaries with breast cancer. Breast Cancer Research And Treatment 2013, 141: 155-163. PMID: 23942872, PMCID: PMC3893026, DOI: 10.1007/s10549-013-2656-1.Peer-Reviewed Original ResearchConceptsPreoperative breast magnetic resonance imagingBreast magnetic resonance imagingBreast-conserving surgeryMagnetic resonance imagingBreast cancerSurgical approachBilateral cancerMRI useOlder womenAssociation of MRIEnd Results-Medicare databasePreoperative MRI useContralateral prophylactic mastectomyType of surgeryCohort of womenBilateral mastectomyUnilateral mastectomyProphylactic mastectomyMastectomyMedicare beneficiariesSurgeryResonance imagingClinical implicationsCancerInvasive surgery