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

OCS Liver System Moves One Step Closer To Approval After Panel Recommendation

Executive Summary

A panel of medical experts recommended that the US Food and Drug Administration grant premarket approval to a system designed to preserve and monitor livers destined for transplant recipients.

You may also be interested in...



FDA Reviewers Raise Concerns About Value Of TransMedic’s OCS Liver System Trial Data

As experts convene to discuss whether to recommend approval of the device, agency reviewers are concerned about what the primary endpoint and organ selection criteria used in trials mean for safety and efficacy.

FDA Increases Premarket Application Fees Again This Year, But Not By As Much

Fees for filing a premarket application with the US FDA increased 2.5% for fiscal year 2022, which is significantly less than the 7% they went up last year. 

Many Device-Related Deaths Are Not Being Accurately Reported To FDA, Study Claims

Research from the University of California, San Francisco claims that many deaths involving medical devices are incorrectly reported to the US agency, and says improving the accuracy of how these deaths are classified could improve patient safety.

Topics

UsernamePublicRestriction

Register

MT144218

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