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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
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

Selecting the Appropriate Continuous Glucose Monitoring System – a  Practical Approach | [current-page:pager]touchENDOCRINOLOGY
Selecting the Appropriate Continuous Glucose Monitoring System – a Practical Approach | [current-page:pager]touchENDOCRINOLOGY

Biosensors | Free Full-Text | Consistency of Continuous Ambulatory  Interstitial Glucose Monitoring Sensors
Biosensors | Free Full-Text | Consistency of Continuous Ambulatory Interstitial Glucose Monitoring Sensors

Summary of Safety and Effectivness (SSED)Template
Summary of Safety and Effectivness (SSED)Template

Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop
Guardian™ Sensor 3 for the MiniMed™ 670G/630G system (5/box) | Diabetes Shop

Continuous Glucose Monitoring Overview: Features and Evidence
Continuous Glucose Monitoring Overview: Features and Evidence

Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment  of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions
Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions | Circulation: Cardiovascular Interventions

PDF) Adverse event using Medtronic NIM™ EMG endotracheal tube on a patient  receiving anesthesia for hemithyroidectomy: a case report
PDF) Adverse event using Medtronic NIM™ EMG endotracheal tube on a patient receiving anesthesia for hemithyroidectomy: a case report

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
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

An FDA Viewpoint on Unique Considerations for Medical-Device Clinical  Trials | NEJM
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM

Cybersecurity features of digital medical devices: an analysis of FDA  product summaries. - Abstract - Europe PMC
Cybersecurity features of digital medical devices: an analysis of FDA product summaries. - Abstract - Europe PMC

Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical  Practice - Davida F. Kruger, Steve V. Edelman, Deborah A. Hinnen,  Christopher G. Parkin, 2019
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
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology

Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology,  Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf
Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control - Endotext - NCBI Bookshelf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Frontiers | Advancing Regulatory Science With Computational Modeling for  Medical Devices at the FDA's Office of Science and Engineering Laboratories
Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories

Navigating the Regulatory Pathway for Medical Devices—a Conversation with  the FDA, Clinicians, Researchers, and Industry Experts | SpringerLink
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
P160017/S031: FDA Summary of Safety and Effectiveness Data Page 1 SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL IN

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.
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.

PDF) Study Design and Data Analysis of Artificial Pancreas Device Systems  with Closed-Loop Glucose-Sensing Insulin Delivery
PDF) Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery

Performance of a new real‐time continuous glucose monitoring system: A  multicenter pilot study - Zhou - 2018 - Journal of Diabetes Investigation -  Wiley Online Library
Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study - Zhou - 2018 - Journal of Diabetes Investigation - Wiley Online Library

Medical devices, smart drug delivery, wearables and technology for the  treatment of Diabetes Mellitus - ScienceDirect
Medical devices, smart drug delivery, wearables and technology for the treatment of Diabetes Mellitus - ScienceDirect

Off Labeled Drugs
Off Labeled Drugs

CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen)
CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen)

Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report |  SpringerLink
Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report | SpringerLink