Medical Device Network

Bayer secures expanded FDA clearances for MRI contrast agent injector

The FDA's expanded clearances broaden the application of Bayer's Medrad MRXperion system across a wider range of MR settings.

FDA Approves VUEWAY® (gadopiclenol) Solution for Injection, Intravenous Use, for Use in Neonates and Infants

Bracco, a global leader in diagnostic imaging, today announced that the U.S. Food and Drug Administration (FDA) has approved ...
Nasdaq

GE Healthcare Announces U.S. FDA Approval of Macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) Injection for Intravenous Use

Clariscan, approved in more than 55 countries globally with over four million patient doses shipped, is now FDA-approved in the U.S. Expands the GE Healthcare portfolio of contrast media products “The ...

New FDA 510(k) Clearance Expands Bayer’s MEDRAD® MRXperion MR Injection System Support Across Diverse Range of MR Environments

Bayer today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for expanded capabilities of ...
BioSpace

New indication in pediatric patients, including term neonates for Guerbet’s half-dose GBCA, Elucirem™ (Gadopiclenol) Injection

Guerbet's innovation, Elucirem™ is the first gadolinium-based contrast agent approved at half dose of gadolinium, and with the highest relaxivity, in comparison to other availab ...
Business Wire

GE Healthcare’s Clariscan™ (gadoterate meglumine) Becomes Only FDA-Approved MRI Contrast Agent Available in Polymer Bottle

MARLBOROUGH, Mass.--(BUSINESS WIRE)--GE Healthcare’s innovative shatterproof polymer +PLUSPAK Pharmacy Bulk Package has been approved by the US FDA for use with its macrocyclic gadolinium-based MRI ...
Business Wire

Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies

BERLIN--(BUSINESS WIRE)--Bayer, a global leader in radiology, today announced positive topline results of the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane, an ...
FOX40 News

Cision PR Newswire

PRINCETON, N.J., Nov. 11, 2024 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, is proud to announce ...
HUB

Adult research volunteers needed for MRI study with contrast agent injection

We are looking for volunteers to undergo magnetic resonance imaging (MRI) scans of the brain, with gadolinium-based contrast agent injection. Participants will be paid $80. The total scan duration is ...