Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Medtronic Gets Extra FDA Attention To Hasten Approval Of Next-Gen Insulin Pump

This article was originally published in The Gray Sheet

Executive Summary

CDRH has formed a close working partnership with Medtronic to facilitate quick approval for a next-generation insulation pump-glucose monitor, offering an illustration of what the center’s future plans might be for addressing devices with breakthrough potential.

You may also be interested in...



US FDA Approves First 'Artificial Pancreas' In Medtronic's MiniMed 670G

The hybrid closed-loop automated insulin delivery system, the first closed-loop system approved anywhere in the world, automatically monitors glucose and provides appropriate basal insulin doses in people with type 1 diabetes.

Medtronic Launches U.S. Trial For Predictive Glucose Monitor-Pump System

The single-arm pivotal trial is assessing the firm's next-generation diabetes system, which adds predictive algorithm features and a smaller sensor compared to the currently marketed MiniMed 530G low-glucose suspend device, marking another step towards an artificial pancreas, Medtronic says.

Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway

The newly proposed “expedited access” PMA program combines early and outsized interactions between reviewers and manufacturers with the promise of lightened premarket requirements for selected products – if the potential payoff to patients is large enough and postmarket controls are sufficient.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032942

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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