Clinical Evidence Supporting FDA Clearance of First-of-a-Kind Therapeutic Devices via the De Novo Pathway Between 2011 and 2019 | medRxiv
Endovascular Treatment of Popliteal Artery Occlusion Caused by a Ruptured Supera Interwoven Nitinol Stent - Annals of Vascular Surgery
Bayesian statistical method was underused despite its advantages in the assessment of implantable medical devices - Journal of Clinical Epidemiology
Compassionate use of drugs and medical devices in the United States, the European Union and Japan. - Abstract - Europe PMC
Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis - American Journal of Cardiology
Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories | Medicine
Overview and experience of the YODA Project with clinical trial data sharing after 5 years | Scientific Data
Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Systematic Review and Meta-Analysis | JACC: Clinical Electrophysiology
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | Gore Medical
Digitizing clinical trials | npj Digital Medicine
100 years of insulin: celebrating the past, present and future of diabetes therapy | Nature Medicine
Is the New Automated Insulin Pump Really an Artificial Pancreas?—Commentary - MSD Manual Professional Edition
Hot Topics in FDA Law Contact: Barbara Evans, Office BLB 214
Effectiveness of reprocessing ureteroscopes, other endoscopic devices - OR Manager
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions
Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker - Heart Rhythm
Technological innovation of Continuous Glucose Monitoring (CGM) as a tool for commercial aviation pilots with insulin-treated diabetes and stakeholders/regulators: A new chance to improve the directives? - Diabetes Research and Clinical Practice
PDF) Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: Systematic review and meta-analysis
Compassionate use of drugs and medical devices in the United States, the European Union and Japan. - Abstract - Europe PMC
Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems | Therapeutic Delivery
Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories | Medicine
PDF) Continuous glucose monitoring devices: A brief presentation (Review)
Phase 1/2a, open‐label, multicenter study of RM‐1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma - Cognetti - 2021 - Head & Neck - Wiley Online Library
Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for U.S. Food and Drug Administration approval and postmarket surveillance of endoscopic devices - Gastrointestinal Endoscopy
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
The relevance of skull density ratio in selecting candidates for transcranial MR-guided focused ultrasound in: Journal of Neurosurgery Volume 132 Issue 6 (2019) Journals
PDF) Maintaining safety and efficacy for 3D printing in medicine
Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial - Journal of Vascular Surgery
