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

Vertiflex Superion Spacer Panel Reset To Give FDA More Review Time

This article was originally published in The Gray Sheet

Executive Summary

FDA's Orthopaedics and Rehabilitation Devices Panel had planned to consider Vertiflex's PMA for its Superion interspinous spacer device on Dec. 12, but the agency postponed the meeting to Feb. 20 give it more time to review device information.

You may also be interested in...



Ekso's Exoskeleton Receives Medicare Coverage, Paves Way To Faster Rehabilitation

Ekso Bionics’ exoskeleton received a final payment determination from the Centers for Medicare and Medicaid Services, paving the way to faster rehabilitation for more patients.

EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Women’s Voices For The Earth Will Keep After CIR, Salon Worker Safety In 2024

Women’s Voices for the Earth continues to call attention to cosmetic ingredients’ potential health impacts on users including salon workers, while pushing the Cosmetic Ingredient Review to consider a wider variety of safety information in its assessment work.

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033582

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