Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice - Davida F. Kruger, Steve V. Edelman, Deborah A. Hinnen, Christopher G. Parkin, 2019
PDF) Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: Systematic review and meta-analysis
Cybersecurity features of digital medical devices: an analysis of FDA product summaries. - Abstract - Europe PMC
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
Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report | SpringerLink
P160017/S031: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL IN
Continuous Glucose Monitoring Overview: Features and Evidence
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop
Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study - Zhou - 2018 - Journal of Diabetes Investigation - Wiley Online Library
PDF) Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery
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.
How FDA Regulates Artificial Intelligence in Medical Products | The Pew Charitable Trusts
CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen)
Summary of Safety and Effectivness (SSED)Template
Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions
Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts | SpringerLink
Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes – Oxford Clinical Policy
Summary of Safety and Effectivness (SSED)Template
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
Off Labeled Drugs
This policy addresses policy and coverage guidelines for Implantable and Non-Implantable Continuous Glucose Monitors (CGM) Home
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
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology
