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

Antimicrobial Susceptibility Test-Makers Seek Ways To Shorten FDA Clearance Process

Executive Summary

A group of antimicrobial susceptibility test manufacturers are working with US FDA regulators to hasten the clearance process for their products. The agency recent convened a workshop at its Maryland headquarters to help address the issue.

You may also be interested in...



bioMérieux America CEO Talks Dx Reform Progress, Antibiotic Resistance

Stefan Willemsen, a top executive at diagnostics firm bioMérieux, has been working through AdvaMedDx with FDA, and with US House members to signal industry support for a bill to create a separate diagnostic regulatory framework at FDA. He spoke about that effort and explained how his firm’s products can be helpful in pinpointing cases of antibiotic resistance.

Market Intel: From AI-Based IVDs To Precision Drug Dosing: Medtech Conference 2017 Gives Insight Into Tomorrow's Technologies

The annual AdvaMed conference, rebranded "Medtech Conference" this year, drew more than 2,700 attendees seeking to explore cutting-edge technologies and networking opportunities, as well as to hear from FDA's top officials about new developments. This article takes a closer look at some of the most innovative solutions presented at the event, including machine learning-based diagnostics to combat antimicrobial resistance, a ureter-locating device, virtual reality technologies to enhance orthopedic surgery and precision drug dosing, among other things.

White House To Deliver 25 Million Face Masks To Low-Income Americans

The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT121498

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