Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes – Oxford Clinical Policy
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | Gore Medical
Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice - Davida F. Kruger, Steve V. Edelman, Deborah A. Hinnen, Christopher G. Parkin, 2019
Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories
Cybersecurity features of digital medical devices: an analysis of FDA product summaries. - Abstract - Europe PMC
P160017/S031: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL IN
Summary of Safety and Effectivness (SSED)Template
Medical devices, smart drug delivery, wearables and technology for the treatment of Diabetes Mellitus - ScienceDirect
Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study - Zhou - 2018 - Journal of Diabetes Investigation - Wiley Online Library
PDF) Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: Systematic review and meta-analysis
This policy addresses policy and coverage guidelines for Implantable and Non-Implantable Continuous Glucose Monitors (CGM) Home
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
Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
Off Labeled Drugs
How FDA Regulates Artificial Intelligence in Medical Products | The Pew Charitable Trusts
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
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report | SpringerLink
PDF) Adverse event using Medtronic NIM™ EMG endotracheal tube on a patient receiving anesthesia for hemithyroidectomy: a case report
CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen)
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
