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Cybersecurity features of digital medical devices: an analysis of FDA product summaries. - Abstract - Europe PMC
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SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
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Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
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PDF) Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: Systematic review and meta-analysis
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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
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
Off Labeled Drugs
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
Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report | SpringerLink
Continuous Glucose Monitoring Overview: Features and Evidence
Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts | SpringerLink
P160017/S031: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL IN
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors
How FDA Regulates Artificial Intelligence in Medical Products | The Pew Charitable Trusts
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
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | Gore Medical
This policy addresses policy and coverage guidelines for Implantable and Non-Implantable Continuous Glucose Monitors (CGM) Home
PDF) Adverse event using Medtronic NIM™ EMG endotracheal tube on a patient receiving anesthesia for hemithyroidectomy: a case report
