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An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
P160017/S031: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL IN
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China | PLOS Medicine
Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts | SpringerLink
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
Continuous Glucose Monitoring Overview: Features and Evidence
Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop
This policy addresses policy and coverage guidelines for Implantable and Non-Implantable Continuous Glucose Monitors (CGM) Home
PDF) Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: Systematic review and meta-analysis
Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline - Rodolfo J. Galindo, Guillermo E. Umpierrez, Robert J. Rushakoff, Ananda Basu, Suzanne Lohnes, James H. Nichols, Elias K.
Off Labeled Drugs
Cybersecurity features of digital medical devices: an analysis of FDA product summaries. - Abstract - Europe PMC
Summary of Safety and Effectivness (SSED)Template
PDF) Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system | Atsushi Hirohata - Academia.edu
Medical devices, smart drug delivery, wearables and technology for the treatment of Diabetes Mellitus - ScienceDirect
PDF) Adverse event using Medtronic NIM™ EMG endotracheal tube on a patient receiving anesthesia for hemithyroidectomy: a case report
Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice - Davida F. Kruger, Steve V. Edelman, Deborah A. Hinnen, Christopher G. Parkin, 2019
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study - Zhou - 2018 - Journal of Diabetes Investigation - Wiley Online Library
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories
