Lowest-dose MRI contrast in the U.S.: Bayer's AMBELVIST arrives

Edited by ad hoc news Products & Consumer Desk. Reviewed before publication on 06/15/2026 at 2:00 PM ET. Details in the imprint.

Bayer's AMBELVIST® (gadoquatrane) is now cleared in the U.S. for contrast-enhanced MRI after FDA approval on 06/15/2026, and Bayer says it is the lowest-dose macrocyclic gadolinium-based contrast agent approved in the country. The product is aimed at scans where radiologists need to visualize lesions with abnormal vascularity, which gives the launch a clear clinical use case beyond a simple line extension. Bayer's FDA approval announcement

Why this contrast agent matters for MRI workflows

According to Bayer, the recommended dose is 0.01 mmol/kg actual body weight, which delivers 0.04 mmol Gd/kg body weight, and that is positioned as 60% less gadolinium than contrast agents using 0.1 mmol Gd/kg body weight. That dosage claim is the product's core differentiator and the reason this approval is more than routine regulatory housekeeping. Fierce Pharma coverage

The label covers adult and pediatric patients, including term neonates, and spans both central nervous system and non-CNS body regions. In practical terms, that broad indication gives hospitals a single contrast option for a wide set of MRI exams rather than a narrow specialty product. FDA clearance database

For Bayer, AMBELVIST extends its imaging portfolio into a category where dose, safety profile, and workflow fit all matter in procurement decisions. Bayer shares (ISIN DE000BAY0017) traded on Xetra at EUR 27.41 on 06/15/2026, according to market data from the exchange operator.

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