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FDA approves Guerbet’s Optiray imaging bulk package

By Brian Buntz | December 4, 2020

GuerbetGuerbet (EPA:GBT), which specializes in medical imaging including contrast agents, has received FDA approval for its Optiray imaging bulk package, which can be used to fill sterile disposable syringes for use with CT imaging. 

The imaging bulk package is intended to reduce the number of single-dose vials when used with a power injector and contrast media transfer set. The imaging bulk package does not require a laminar flow hood or pharmacy. 

The package will be offered in 500-ml bottles of the Optiray 320 and 350 concentrations of radiopaque contrast agent. 

The label for the agents stipulates that they be used within 12 hours once the seal is pierced. 

FDA also cleared the Villepinte, France-based company’s LF IBP transfer set. 

Like many life sciences companies, Guerbet has seen a drop in core business activity in 2020 as patients in many regions across the world cancel or postpone nonessential radiological examinations and procedures.

The company’s European sales dropped 21.1% in the first six months of the year. Sales were down by a similar amount in the Americas, although business activity increased by about 10% in Asia. 


Filed Under: Drug Delivery
Tagged With: contrast agents, CT imaging, Guerbet, imaging bulk package
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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