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

Despite Data Concerns, Panel Recommends First-In-Class Toe Implant

This article was originally published in The Gray Sheet

Executive Summary

Cartiva, a toe implant to treat osteoarthritis, received a strong recommendation from a panel of FDA experts despite suggestions that the device had not fully proven itself.

You may also be interested in...



Advisory Panel Recommends Approval For Link’s STAR Ankle Replacement

An FDA advisory panel recommended approval of Link Orthopedics' STAR ankle replacement system April 24 despite FDA reviewers' conclusion that results of the firm's pivotal trial are unclear

Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

The Rebate Rule May Not Last, But It Changed The Pricing Debate

Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.

Topics

Related Companies

UsernamePublicRestriction

Register

OM004559

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