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

Brain Trust Advises US FDA On Aneurysm Device Trials

Executive Summary

To help figure out how intracranial aneurysm devices should be evaluated in clinical trials, US FDA brought together its Neurological Devices Advisory Panel. The experts answered questions ranging from safety and efficacy endpoints that should be taken into consideration to post-market study requirements.

You may also be interested in...



Neuro Panel Takeaways: Detailed Responses On Aneurysm Devices From US FDA Advisors

Point-by-point clinical trial recommendations from US FDA's Neurological Devices Advisory Panel at a recent meeting on intracranial aneurysm devices.

FDA's US-First Strategy: Device Center Sets Three-Year Goals

A new three-year plan to implement strategic priorities at US FDA's device center aims to make several broad improvements to the medtech ecosystem. Among them is improving staff incentives at the agency, creating more partnerships with industry and other stakeholders, and improving the center's processes to make it easier for novel medical devices to enter the US market.

Experts Recommend Requiring Randomized Trials For Flow Diverter PMAs

FDA's Neurological Devices Panel says sponsors should be required to conduct randomized controlled trials for aneurysm treatment devices such as flow diverters and should only be allowed to use performance goal studies as a last resort to support approval.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT122287

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