SEARCH
Current Location:
>
> This Story

starstarstarstarstar (1)
Log in or Register to rate this News Story
Forward Printable StoryPrint Comment

Never Miss a Story

Sign up for email alerts

 

More Industry Headlines

Announcing the 'Rosetta Stone' of advanced prostate cancer Researchers say prostate cancer not a "single disease" but 90 percent of cases yield actionable mutations

Surgical robotic device market to grow over 600 percent by 2021 Will jump from $3.2 billion to $20 billion

New radiation blood test awaits human application Research funded by feds to save lives offers faster, cheaper testing

Scientists embed electrodes in yarn, paving the way for true wearable devices 'Wearing your heart on your sleeve' may take on a whole new meaning

ACR 2015: Three hot trends in imaging Times are changing — and so is radiology

Siemens' PETNET Solutions receives U.S. rights to prostate PET/CT agent Will manufacture and distribute Fluciclovine, a radiopharmaceutical under clinical evaluation

Philips and MIT enter $25 million alliance, talk long-term goals Philips research hub is coming to Cambridge with patient monitoring top-of-mind

Raising the bar on EHRs: Getting the 21st Century Cures Act right Legislation asks for $10 million to improve EHR interoperability, AHA says don't take it from hospitals

ACR 2015: Dr. James Thrall on imaging in the era of precision medicine Radiologists are already doing more than they think

UK experts urge $2 billion for development of antibiotics Antibiotic resistant microbes could kill 10 million people a year worldwide by 2050

Bracco gets FDA nod to expand Multihance indications

by Brendon Nafziger , DOTmed News Associate Editor
Bracco Diagnostics Inc. said Friday it received Food and Drug Administration approval to expand the indications of an MRI imaging agent used to detect brain tumors to now cover certain types of arterial disease.

Bracco said the drug, Multihance (gadobenate dimeglumine), now has been expanded for use in magnetic resonance angiographies to help diagnose stenosis in the renal and aorto-ilio-femoral arteries. The gadolinium-based contrast agent was originally approved by the FDA in 2004 for MRI scans of the central nervous system in children and adults.

Story Continues Below Advertisement

There's never been a better time - or an easier way to excel

Partner with Siemens to achieve success. At Siemens, service means more than fixing what breaks. It means providing you with the education, tools and support you need to work smarter. Click above to learn more



The company said the approval came about after Bracco conducted two large, multi-center, prospective trials on the new indication.

As with other GBCAs, Multihance carries a black box warning label because of the risk of nephrogenic systemic fibrosis, believed to be an extremely rare side effect for patients with kidney problems who receive GBCA injections. However, in a statement, Dr. Alberto Spinazzi, senior vice president of regulatory affairs with Bracco, said Multihance carries a "strong record of safety" and has been administered more than 14 million times.

"Multihance has long been distinguished in the MRI of the CNS as a gadolinium-based contrast agent characterized by a strong increase in relaxivity in any medium containing serum proteins, contributing to increased contrast-to-noise ratio and lesion-to-brain ratio and improved visualization," he said.

Bracco Group is headquartered in Milan, Italy.

Related:


Interested in Medical Industry News? Subscribe to DOTmed's weekly news email and always be informed. Click here, it takes just 30 seconds.

You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2015 DOTmed.com, Inc.
ALL RIGHTS RESERVED