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

Acclarent Pays $18m To Settle False-Claims Allegations

Executive Summary

The one-time payment will put to rest government claims that Acclarent marketed its Relieva Stratus device for off-label use. Two former Acclarent execs were found guilty of misdemeanors last week in a related case.

You may also be interested in...



Acclarent Execs Move To Appeal Off-Label Conviction

Attorneys for former Acclarent executives William Facteau and Patrick Fabian have filed a request that their convictions on off-label marketing charges either be set aside or that they be granted a new trial, citing other recent off-label trials and misconduct by the government.

Former Acclarent Execs Convicted Of Misdemeanors In Off-Label Case

Two former executives from J&J's Acclarent division were found not guilty of felony charges but convicted on misdemeanor counts. Prior to being acquired by J&J, Acclarent allegedly marketed its Relieva Stratus sinus dilation device as a steroid-delivery system, even though the FDA had cleared the device only to deliver saline.

‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports

The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT103643

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