Device Approval

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  Subject Areas on Research

  • A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials. 
  • A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study). 
  • Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015. 
  • Biomedical innovation: a risky business at risk. 
  • Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock. 
  • Clinical trials in peripheral vascular disease: pipeline and trial designs: an evaluation of the ClinicalTrials.gov database. 
  • Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review. 
  • Differences in the approval process for interventional devices in Europe and USA: IN MEDIO STAT VIRTUS. 
  • Drug-eluting stents "deliver heartburn": how do we spell relief going forward? 
  • Economic implications of potential changes to regulatory and reimbursement policies for medical devices. 
  • Electroconvulsive therapy device classification: response to FDA advisory panel hearing and recommendations. 
  • Endovascular repair of descending thoracic aneurysms: results with "on-label" application in the post Food and Drug Administration approval era. 
  • Evidence strength in FDA premarket approval of cardiovascular devices. 
  • Exploring options for improving healthcare. 
  • Generating comparative evidence on new drugs and devices after approval. 
  • Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials: A Call to Action From the Value in Healthcare Initiative's Partnering With Regulators Learning Collaborative. 
  • Incontinence: should mesh be used to correct anterior vaginal prolapse? 
  • Inventing in orthopaedics: from idea to marketed device. 
  • Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model. 
  • Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective. 
  • Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective. 
  • Not Your Mother's FDA. 
  • Part I: Identifying holes in the safety net. 
  • Part II: Sealing holes in the safety net. 
  • Pediatric cardiovascular safety: challenges in drug and device development and clinical application. 
  • Permanently implantable diagnostic computerized devices: where is the regulatory rar? 
  • Postmarket evaluation of breakthrough technologies. 
  • Precision diagnosis: a view of the clinical decision support systems (CDSS) landscape through the lens of critical care. 
  • Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities. 
  • Randomized Controlled Trials in Functional Neurosurgery-Association of Device Approval Status and Trial Quality. 
  • Recommendations for the Use of Mechanical Circulatory Support: Ambulatory and Community Patient Care: A Scientific Statement From the American Heart Association. 
  • Recommendations of the OARSI FDA Osteoarthritis Devices Working Group. 
  • Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements. 
  • Regulation Without Representation: Cardiac Device Patient Knowledge and Attitudes About the FDA Regulatory Process. 
  • Regulatory device approval for stroke: fair and balanced? 
  • Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). 
  • Shoulder arthroplasty device clearance: an ancestral network analysis. 
  • Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States. 
  • Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States: executive summary. 
  • The "ideal" replacement heart valve. 
  • The 21st Century Cures Act. 
  • The Interconnected Ancestral Network of Hip Arthroplasty Device Approval. 
  • Value in Healthcare Initiative: Summary and Key Recommendations. 
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  Keywords of People

  • Reed, Shelby Derene, Professor in Population Health Sciences, Duke Science & Society
  • Sullivan, Daniel Carl, Professor Emeritus of Radiology, Radiology