Medtech Insight is part 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


Chart: Amplify: A "De-Risk" Approval?

This article was originally published in The Gray Sheet

Executive Summary

If FDA does approve Amplify, it is not clear that the decision will immediately add a significant amount of new sales for Medtronic, but it could help relieve some pressure on the firm's spine biologics franchise, which is under scrutiny on various fronts.

You may also be interested in...

Regulatory News In Brief

Updated FDA review clock guidance: Agency issues June 30 1guidance detailing the different actions FDA may take on pre-market approval applications and clarifying FDA's timeline goals for applications filed from FY 2008-2012 versus those filed from FY 2003-2007. The 2007 FDA Amendments Act removed interim cycle goals, which often stopped the "review clock" and inadvertently prolonged the review process, maintaining FDA decision goals only. FDA will follow the review goals proposed as part of the new user fee legislation (2"The Gray Sheet" April 23, 2007, p. 7). Cycle goals are also abolished for applications filed in FY 2007. Performance goals will no longer vary from year to year, and FDA now has the option of issuing major deficiency letters for 180-day supplements, as well as for PMAs and panel-track supplements, the guidance points out. The document replaces October 2003 guidance based on the review clock in the 2002 user fee legislation (3"The Gray Sheet" Oct. 13, 2003, p. 22)

Abbott Launches Five-Minute POC Rapid COVID-19 Test

Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.

In A Bizarre Move, Trump Orders GM To Make Ventilators – Even Though The Auto Giant Already Is

President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.





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