Medtech Insight is part of the Business Intelligence Division 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

Medtronic Infuse Saga Prompts Questions About FDA Approval Process

This article was originally published in The Gray Sheet

Executive Summary

Medtronic, responding last week to suggestions in the Spine Journal that financial ties to the company led researchers to hide serious adverse events associated with the firm's Infuse bone graft when writing up their studies for publication, defended itself by pointing out that the data on which FDA based its approval of the product contained no such omissions.
Advertisement

Related Content

No Advantage For Medtronic’s InFuse Versus Bone Graft In Spine Fusion
Infuse Open-Access Project A Model For The Future? Medtronic Thinks So
No Advantage For Medtronic’s InFuse Versus Bone Graft In Spine Fusion
Data In The Raw: Yale Doc Hopes Medtronic Infuse Effort Will Spark Data Transparency Model
News In Brief
News In Brief
Infuse Gets A Lashing In Spine Journal Over New Sterility Data
Infuse Gets A Lashing In Spine Journal Over New Sterility Data
Medtronic Mines GE For New Chief; Omar Ishrak Starts In June
Medtronic InFuse Sales Flat In Q2; Firm’s Spine Business Still Struggling

Topics

Advertisement
UsernamePublicRestriction

Register

MT030308

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