SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
Off Labeled Drugs
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
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.
CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen)
Continuous Glucose Monitoring Overview: Features and Evidence
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
PDF) Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery
Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes – Oxford Clinical Policy
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice - Davida F. Kruger, Steve V. Edelman, Deborah A. Hinnen, Christopher G. Parkin, 2019
Summary of Safety and Effectivness (SSED)Template
This policy addresses policy and coverage guidelines for Implantable and Non-Implantable Continuous Glucose Monitors (CGM) Home
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
Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | Gore Medical
PDF) Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: Systematic review and meta-analysis
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan | Scientific Reports
Summary of Safety and Effectivness (SSED)Template
Cybersecurity features of digital medical devices: an analysis of FDA product summaries. - Abstract - Europe PMC
