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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Deltec CozmoTM Insulin Infusion Pump (Model 1700) and Accessories I. GENERAL INFORMAT
FDA Regulation of Medical Devices - EveryCRSReport.com
Untitled
Design and analysis of high-risk medical device clinical trials for diabetes monitoring and treatment: a review | Journal of Pancreatology
Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China | PLOS Medicine
IDE REVIEW MEMORANDUM
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | Gore Medical
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
Management of diabetes and hyperglycaemia in the hospital - The Lancet Diabetes & Endocrinology
510(k) Summary of Safety and Effectiveness
1.01.30 Artificial Pancreas Device Systems
D1()SmayfEC
In vitro stability of biosimilar insulin aspart SAR341402 in the Medtronic MiniMed insulin pumps - Journal of Pharmaceutical Sciences
Frontiers | Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories
![Selecting the Appropriate Continuous Glucose Monitoring System – a Practical Approach | [current-page:pager]touchENDOCRINOLOGY](https://www.touchendocrinology.com/wp-content/uploads/sites/5/2018/02/table1-summary-of-char.png "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
Clinical Evidence Supporting FDA Clearance of First-of-a-Kind Therapeutic Devices via the De Novo Pathway Between 2011 and 2019 | medRxiv
100 years of insulin: celebrating the past, present and future of diabetes therapy | Nature Medicine
Guidance for Industry
Bioengineering | Free Full-Text | Impact of an Accessory for Left Ventricular Assist Devices on Device Flow and Pressure Head In Vitro
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials | NEJM
The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases - The American Journal of Medicine
July 2011 digital edition of Pharmacy Practice News by McMahon Group - Issuu
Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study - The Lancet Neurology
