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


NMT Medical CardioSeal

This article was originally published in The Gray Sheet

Executive Summary

Septal occluder cardiac implant receives second FDA humanitarian use designation approval, expanding use to include closure of ventricular septal defects that cannot be closed using standard surgical approaches, the firm announces Sept. 28. On Sept. 9, NMT announced FDA approval for humanitarian use (under 4,000 patients) of the device to close fenestrated Fontan procedures (1"The Gray Sheet" Sept. 13, In Brief)

You may also be interested in...

NMT Medical CardioSeal

Septal occluder cardiac implant gains FDA humanitarian use designation approval for closing fenestrated Fontan procedures. Designed to close holes in the heart, the device is in clinical trials for "broader approval," NMT says. The HUD allows treatment of up to 4,000 patients per year

Podcast: Scrip’s Asia Team Dissects Pharma’s Response To Coronavirus

Scrip’s on-the-ground team in Asia talks about how the regional and wider pharma industry and policymakers have responded so far to the spreading coronavirus outbreak, with a focus on the expedited development of potential drugs and vaccines.

Lilly’s Cyramza Wins Slim Nod, But Steba’s Tookad Falls Hard At US FDA Panel

Oncologic Drugs Advisory Committee votes 6-5 that ramucirumab’s benefit/risk profile is favorable in first-line lung cancer, but 13-2 that pivotal trial data do not support approval of Steba’s vascular-targeted, photodynamic therapy for low-risk prostate cancer.




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