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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
Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop
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Medical devices, smart drug delivery, wearables and technology for the treatment of Diabetes Mellitus - ScienceDirect
Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China | PLOS Medicine
Continuous Glucose Monitoring Overview: Features and Evidence
Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice - Davida F. Kruger, Steve V. Edelman, Deborah A. Hinnen, Christopher G. Parkin, 2019
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An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | Gore Medical
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions
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
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology
This policy addresses policy and coverage guidelines for Implantable and Non-Implantable Continuous Glucose Monitors (CGM) Home
Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report | SpringerLink
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Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study - Zhou - 2018 - Journal of Diabetes Investigation - Wiley Online Library
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
PDF) Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery
