Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

EV3 catheter recall: Firm recalls about 350 TrailBlazer support catheters Nov. 6 after receiving reports from physicians of cracking near the radiopaque marker band during the product's limited initial U.S. release. The malfunction could cause injuries such as insufficient oxygen supply to tissues, damage to blood vessels, heart attack or death, FDA said Jan. 5. The firm says the Class I recall was completed in December and all affected units have been returned to the company. A redesigned TrailBlazer support catheter was launched last month and is available worldwide, ev3 notes

You may also be interested in...



Electronic medical device reporting update

Companies may begin using new FDA device problem codes in their mandatory adverse event reports beginning July 1, the agency says. The new electronic Medical Device Reporting (eMDR) coding 1system revamps the previous system with specific improvements to patient and device problem codes, the inclusion of component codes to clarify the part of the device associated with the adverse event, and improvements to code descriptions and definitions, FDA says. Old MDR codes will still be accepted, but only until April 2, 2010 (2"The Gray Sheet" April 6, 2009)

Australia Relaxes Competition Rules To Facilitate Coronavirus Response

Australia’s competition regulator, the ACCC, has granted a conditional dispensation to allow generics industry association the GBMA and brand body Medicines Australia to work together to help address the coronavirus pandemic by sharing information on stock, inventory, manufacturing and the supply chain. However, tender pricing will not be among the subjects discussed.

Interview: Izana Tests GM-CSF Drug For Coronavirus

The UK biotech's CEO tells Scrip that Izana's objective is to treat rapidly deteriorating COVID-19 patients before ICU admission and prior to ventilation.

Topics

UsernamePublicRestriction

Register

MT028365

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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