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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Will Relax Premarket Requirements To Enable LVAD Randomized Trials

This article was originally published in The Gray Sheet

Executive Summary

Randomized, controlled trials supporting PMAs for left-ventricular assist devices as destination therapy should compare the investigational device with an already approved LVAD, according to FDA

You may also be interested in...



Who’s In Control? Thoratec, Investigators Discuss Access To NIH-Funded Data

Thoratec is in negotiations with NIH to restrict access to control group data from the REMATCH randomized trial of the HeartMate VE upon the study's completion

Cosmetics Weekly Trademark Review: 14 January 2020

Personal-care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps.

Cosmetics Weekly Trademark Review: 7 January 2020

Personal-care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps.
UsernamePublicRestriction

Register

MT017967

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