Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Artificial Pancreas Guidance Allows For More Flexibility In Trial Design

This article was originally published in The Gray Sheet

Executive Summary

FDA’s final guidance on the design and clinical study of artificial pancreas systems broadens the study endpoints permissible for the devices, which aim to “close the loop” in the treatment of type 1 diabetes.

Advertisement

Related Content

Diabetes Endpoints, CV Requirements Get Special Handling At FDA-Patient Meeting
Medtronic Gets Extra FDA Attention To Hasten Approval Of Next-Gen Insulin Pump
The Artificial Pancreas: A Race To The Finish
The Artificial Pancreas: A Race To The Finish
News Briefs: Medtronic’s First-Gen Artificial Pancreas Approved; CMS Removes Bariatric Surgery Requirements
CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role
CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role
DexCom: The Beauty Of Open Architecture
Regulatory News In Brief
FDA Releases Draft Guidance On Closed-Loop Artificial Pancreas Devices

Topics

Advertisement
UsernamePublicRestriction

Register

MT031736

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel