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Flash Glucose Monitoring: A Patient's and Clinician's Caveats and Concerns - Endocrine Practice
Flash Glucose Monitoring: A Patient's and Clinician's Caveats and Concerns - Endocrine Practice

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

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

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes – Individual Exchange Medical Policy
Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes – Individual Exchange Medical Policy

0070 Diabetes Tests- Programs and Supplies (1)
0070 Diabetes Tests- Programs and Supplies (1)

How FDA Regulates Artificial Intelligence in Medical Products | The Pew Charitable Trusts
How FDA Regulates Artificial Intelligence in Medical Products | The Pew Charitable Trusts

American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus - Endocrine Practice
American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus - Endocrine Practice

Glucose Monitoring:
Glucose Monitoring:

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

1.01.30 Artificial Pancreas Device Systems
1.01.30 Artificial Pancreas Device Systems

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

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

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

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

Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline
Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline

Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology

Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline
Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline

Continuous Glucose Monitor (CGM)
Continuous Glucose Monitor (CGM)

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

SSED Template
SSED Template

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

Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice
Reference Guide for Integrating Continuous Glucose Monitoring Into Clinical Practice

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

510(k) Summary of Safety and Effectiveness
510(k) Summary of Safety and Effectiveness

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

IDE REVIEW MEMORANDUM
IDE REVIEW MEMORANDUM

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

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

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Deltec CozmoTM Insulin Infusion Pump (Model 1700) and Accessories I. GENERAL INFORMAT
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Deltec CozmoTM Insulin Infusion Pump (Model 1700) and Accessories I. GENERAL INFORMAT

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

August 31, 2020 Medtronic Minimed, Inc. Nicole Birch Senior Regulatory Affairs Specialist 18000 Devonshire Street Northridge, CA
August 31, 2020 Medtronic Minimed, Inc. Nicole Birch Senior Regulatory Affairs Specialist 18000 Devonshire Street Northridge, CA