Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories
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.
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Summary of Safety and Effectivness (SSED)Template
Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts | SpringerLink
Insulin Lispro with Continuous Subcutaneous Insulin Infusion is Safe and Effective in Patients With Type 2 Diabetes: A Randomized Crossover Trial of Insulin Lispro Versus Insulin Aspart* - Endocrine Practice
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Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report | SpringerLink
Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice - Davida F. Kruger, Steve V. Edelman, Deborah A. Hinnen, Christopher G. Parkin, 2019
Continuous Glucose Monitoring Overview: Features and Evidence
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Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
Medical devices, smart drug delivery, wearables and technology for the treatment of Diabetes Mellitus - ScienceDirect
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | Gore Medical
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
PDF) Adverse event using Medtronic NIM™ EMG endotracheal tube on a patient receiving anesthesia for hemithyroidectomy: a case report
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
This policy addresses policy and coverage guidelines for Implantable and Non-Implantable Continuous Glucose Monitors (CGM) Home
P160017/S031: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL IN
