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

FDA Approves Companion Diagnostic For Obesity Drug

Executive Summary

The US FDA has given thumbs-up to a genetic test from PreventionGenetics, the first agency-approved class II molecular companion diagnostic that looks for genetic deficiencies associated with obesity.

You may also be interested in...



Another Class I Recall For Datascope’s Aortic Balloon Pumps

Datascope/Getinge has initiated another recall of its Intra-Aortic Balloon Pumps, this time for a potentially faulty cable connection.

News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More

News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.

FDA Clears Diagnostic Aimed At Reducing STDs In Women

The US Food and Drug Administration has granted 510(k) clearance to Visby Medical for its product designed to diagnose three of the most common sexually transmitted infections in women.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145577

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