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

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

PDF) Maintaining safety and efficacy for 3D printing in medicine
PDF) Maintaining safety and efficacy for 3D printing in medicine

Phase 1/2a, open‐label, multicenter study of RM‐1929 photoimmunotherapy in  patients with locoregional, recurrent head and neck squamous cell carcinoma  - Cognetti - 2021 - Head & Neck - Wiley Online Library
Phase 1/2a, open‐label, multicenter study of RM‐1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma - Cognetti - 2021 - Head & Neck - Wiley Online Library

Endoscopic transmission of carbapenem-resistant Enterobacteriaceae:  implications for U.S. Food and Drug Administration approval and postmarket  surveillance of endoscopic devices - Gastrointestinal Endoscopy
Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for U.S. Food and Drug Administration approval and postmarket surveillance of endoscopic devices - Gastrointestinal Endoscopy

Overview and experience of the YODA Project with clinical trial data  sharing after 5 years | Scientific Data
Overview and experience of the YODA Project with clinical trial data sharing after 5 years | Scientific Data

PDF) Efficacy and safety comparison of continuous glucose monitoring and  self-monitoring of blood glucose in type 1 diabetes: Systematic review and  meta-analysis
PDF) Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes: Systematic review and meta-analysis

Hot Topics in FDA Law Contact: Barbara Evans, Office BLB 214
Hot Topics in FDA Law Contact: Barbara Evans, Office BLB 214

Technological innovation of Continuous Glucose Monitoring (CGM) as a tool  for commercial aviation pilots with insulin-treated diabetes and  stakeholders/regulators: A new chance to improve the directives? - Diabetes  Research and Clinical Practice
Technological innovation of Continuous Glucose Monitoring (CGM) as a tool for commercial aviation pilots with insulin-treated diabetes and stakeholders/regulators: A new chance to improve the directives? - Diabetes Research and Clinical Practice

Effectiveness of reprocessing ureteroscopes, other endoscopic devices - OR  Manager
Effectiveness of reprocessing ureteroscopes, other endoscopic devices - OR Manager

Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden  Cardiac Death: A Systematic Review and Meta-Analysis | JACC: Clinical  Electrophysiology
Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Systematic Review and Meta-Analysis | JACC: Clinical Electrophysiology

PDF) Current Diabetes Technology: Striving for the Artificial Pancreas
PDF) Current Diabetes Technology: Striving for the Artificial Pancreas

Major adverse clinical events associated with implantation of a leadless  intracardiac pacemaker - Heart Rhythm
Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker - Heart Rhythm

Compassionate use of drugs and medical devices in the United States, the  European Union and Japan. - Abstract - Europe PMC
Compassionate use of drugs and medical devices in the United States, the European Union and Japan. - Abstract - Europe PMC

100 years of insulin: celebrating the past, present and future of diabetes  therapy | Nature Medicine
100 years of insulin: celebrating the past, present and future of diabetes therapy | Nature Medicine

The relevance of skull density ratio in selecting candidates for  transcranial MR-guided focused ultrasound in: Journal of Neurosurgery  Volume 132 Issue 6 (2019) Journals
The relevance of skull density ratio in selecting candidates for transcranial MR-guided focused ultrasound in: Journal of Neurosurgery Volume 132 Issue 6 (2019) Journals

Performance of the Aorfix endograft in severely angulated proximal necks in  the PYTHAGORAS United States clinical trial - Journal of Vascular Surgery
Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial - Journal of Vascular Surgery

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

Bayesian statistical method was underused despite its advantages in the  assessment of implantable medical devices - Journal of Clinical Epidemiology
Bayesian statistical method was underused despite its advantages in the assessment of implantable medical devices - Journal of Clinical Epidemiology

Current perspectives on the US FDA regulatory framework for intelligent  drug-delivery systems | Therapeutic Delivery
Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems | Therapeutic Delivery

GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System |  Gore Medical
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | Gore Medical

Current perspectives on the US FDA regulatory framework for intelligent  drug-delivery systems | Therapeutic Delivery
Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems | Therapeutic Delivery

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

Safety of Sodium-Glucose Co-Transporter 2 Inhibitors - American Journal of  Cardiology
Safety of Sodium-Glucose Co-Transporter 2 Inhibitors - American Journal of Cardiology

Clinical Evidence Supporting FDA Clearance of First-of-a-Kind Therapeutic  Devices via the De Novo Pathway Between 2011 and 2019 | medRxiv
Clinical Evidence Supporting FDA Clearance of First-of-a-Kind Therapeutic Devices via the De Novo Pathway Between 2011 and 2019 | medRxiv

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