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

US FDA Panel To Meet on Transplant IVDs, Test For Managing Antibiotics

Executive Summary

The agency's microbiology devices advisory panel will hold a two-day meeting next month focused on classification of transplant IVDs and potential 510(k) requirements for a test that can help detect and monitor sepsis and other bacterial infection.

You may also be interested in...



FDA To Lower Scrutiny Of CMV Tests Used In Transplant Patients

A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.

Antibiotic Pipeline Profile: Narrowing The Spectrum Of Drug Activity

Development is most advanced in C. difficile infection, but US FDA's exploration of pathways to expedite single pathogen treatments could spur earlier-stage QIDP projects targeting Staphylococcus and Pseudomonas species.

Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217

The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT103908

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