Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts | SpringerLink
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
Continuous Glucose Monitoring Overview: Features and Evidence
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Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes – Oxford Clinical Policy
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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Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice - Davida F. Kruger, Steve V. Edelman, Deborah A. Hinnen, Christopher G. Parkin, 2019
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology
Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop
Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
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An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
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
Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study - Zhou - 2018 - Journal of Diabetes Investigation - Wiley Online Library
Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories
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CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen)
PDF) Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery
PDF) Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: Systematic review and meta-analysis
