title: Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.
abstract: OBJECTIVE
  The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015.
  
  
  METHODS
  This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool.
  
  
  RESULTS
  Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001).
  
  
  CONCLUSIONS
  Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval.
authors.affiliation: Department of Radiology, University of Chicago, Chicago, Illinois. Electronic address: comeron.ghobadi@uchospitals.edu.
authors.forename: Comeron W
authors.initials: CW
authors.lastname: Ghobadi
authors.affiliation: Department of Radiology, Northwestern University, Chicago, Illinois.
authors.forename: Emily L
authors.initials: EL
authors.lastname: Hayman
authors.affiliation: Department of Radiology, University of Chicago, Chicago, Illinois.
authors.forename: Joshua H
authors.initials: JH
authors.lastname: Finkle
authors.affiliation: Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.
authors.forename: Jessica R
authors.initials: JR
authors.lastname: Walter
authors.affiliation: Department of Dermatology, Northwestern University, Chicago, Illinois.
authors.forename: Shuai
authors.initials: S
authors.lastname: Xu
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D018795:Device Approval; D003952:Diagnostic Imaging / Q000295:instrumentation*; D019544:Equipment Failure Analysis / Q000706:statistics & numerical data; D004869:Equipment Safety / Q000706:statistics & numerical data*; D011871:Radiology / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data*
keywords: 21st Century Cures Act; FDA; Medical device innovation; National Evaluation System for Health Technology; health policy; innovation; medical device regulation; patient safety