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

Boston Scientific

This article was originally published in The Gray Sheet

Executive Summary

U.S. Department of Justice initiates inquiry relating to events leading up to the firm's Oct. 5 voluntary recall of its NIR ON Ranger with SOX coronary stent delivery system ("The Gray Sheet" Oct. 12, p. 28). The company "is not aware that [DoJ] is doing anything more than gathering information," Boston states, adding "we do not understand [DoJ's] interest in this matter." Separately, Boston is the subject of a recent class action lawsuit in the U.S. District Court for Massachusetts filed by the law firm of Berger & Montague relating to improperly recorded revenues for Japan ("The Gray Sheet" Nov. 9, p. 5)

You may also be interested in...



Abbott Prism Assays, Spectrum Of Product Launches Stalled By QSR Finding

Approval of Abbott Laboratories' Prism hepatitis B core antibody and HIV-1/2 assays likely will be delayed by FDA's finding that Abbott's Lake County, Illinois diagnostic manufacturing facility still does not comply with quality system regulations, the firm said

Entries Begin To Roll In For 2024 Industry Awards

Entries have now begun rolling in for the Global Generics & Biosimilars Awards, which returns to Milan this October, Free to enter and attend, the ceremony recognizes the top achievements across the generics, biosimilars and value added medicines industries.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT011084

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