Bracco Shapes the Future of Radiology Through MR Innovation

Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., is sharing a bold vision that aims to deliver a sustainable future in radiology. Guided by its four core pillars – innovation, education, sustainability and trust – Bracco is highlighting education and sustainability initiatives that reflect the company’s commitment to partnering with customers and the radiology community to advance patient care while protecting the planet.

Championing Next-Generation Radiology Education

Bracco views education as essential to advancing innovation and collaboration. In 2024, the company provided over $1.4 million in medical education grants to independent third-party organizations, supporting more than 80 accredited programs that, in total, reached over 100,000 healthcare professionals around the world.^1,2,3<

At RSNA this year, Bracco is launching Exploring the Future of MRI Innovation, an immersive and interactive booth learning activity that guides radiologists, technologists, and administrators through a virtual four-room journey spanning the entire MR experience, beginning in the waiting room and concluding with sustainability. The platform will offer peer-reviewed insights and knowledge checks that simulate real-world decision-making scenarios. As part of Bracco’s commitment to advancing education and environmental responsibility, the company will make a corporate donation to independent charitable organizations focused on radiology education and sustainability initiatives. Participants who complete the learning journey will be able to express their preference regarding how Bracco allocates this donation among the designated charitable organizations.

“At RSNA 2025, we’re not just showcasing our vision, we’re inviting the radiology community to step into it,” said Noelle Heber, Executive Director, Radiology Platform, Bracco Americas. “Exploring the Future of MRI Innovation is a hands-on extension of our belief that advancing MR innovation means investing in how we learn, teach, and grow together. It reflects Bracco’s role as a champion of education, a driver of innovation, and a trusted partner in the imaging community.”

Driving Sustainable MR Innovation

VUEWAY® (gadopiclenol) solution for injection, intravenous use is a macrocyclic gadolinium-based contrast agent (GBCA) that recently achieved 3 million doses administered over 900 customer sites in the U.S.^4,5 “This is a significant milestone that reflects both strong market adoption from our hospital partners and growing patient preference for low-dose contrast agents,” said Gary Ray, Associate Director, MR Contrast, Bracco Americas.

VUEWAY injection offers effective contrast enhancement at half the gadolinium (Gd) dose (0.05 mmol/kg) compared to other macrocyclic GBCAs with similar indications in the U.S. (0.1 mmol/kg), helping reduce cumulative Gd exposure in patients without compromising image quality.^6,7,8

In November, the U.S. Food and Drug Administration expanded the indication for the Bracco Max 3™ Rapid Exchange and Syringeless Injector for use in MR procedures. In addition to single-dose vials, the Max 3 system is now indicated for use with VUEWAY^® (gadopiclenol) injection Imaging Bulk Package (IBP) in 30 mL and 50 mL formats. VUEWAY IBP enables delivery of multiple single doses of contrast from one container, ensuring aseptic handling, reduced material waste and more efficient use of contrast agents.

“Today, you might have a patient who needs 5 mL of contrast based on weight, but you have to open a 7.5 mL vial and essentially throw away 2.5 mL. When using VUEWAY IBP with Max 3, you can use the exact amount you need to optimize usage and reduce contrast waste,” said Ray.

Bracco is also showcasing AiMIFY™ software for AI-powered contrast enhancement in brain MR imaging. AiMIFY software amplifies image contrast enhancement up to two times the level obtained with a labeled dose of a GBCA, significantly improving the visibility of small and large lesions compared to standard post-contrast images.⁹

These products reflect Bracco’s vision for the future of MR imaging. “When you can image more efficiently, with less gadolinium and boost brain images, it provides a more sustainable solution – and redefines how the diagnosis is achieved for the patient,” Ray said.

Operational Efficiency and Workflow Transformations

Bracco’s Max 3™ Rapid Exchange and Syringeless Injector System is the first of its kind in the MR space, empowering intuitive, efficient, and easy-to-manage workflow while supporting recommended practices in radiology sustainability. It helps strengthen green efforts in radiology suites because it may help contribute less plastic to healthcare facilities' disposable process and costs. >

When used with VUEWAY IBP, Max 3 allows highly precise, prescriptive dosing – down to the tenth of an mL dose. Technologists can treat multiple patients from a single 30 mL or 50 mL vial, all with the same spike, dramatically reducing contrast waste. Its flexible design accommodates both single-use vials and multi-dose IBPs, allowing facilities to tailor contrast delivery.

“Now the customer has the opportunity to reduce waste and costs while aligning with its sustainability initiatives. With half the gadolinium, using less plastics per procedure and optimizing contrast for less waste, imaging departments have the potential to optimize how contrast is administered in MR,” said Pete Nardell, Senior Director, Injectors and Devices, Bracco Americas.

Looking ahead, Bracco is focused on educating clinicians about the synergy between these technologies, VUEWAY IBP, Max 3 and AiMIFY. “Each product within the MR portfolio complements one another by providing optimal patient care,” Nardell said. “Bracco prioritizes a patient-centric approach to clinical care and these technologies allow for administering contrast in a new and innovative way.”

Corporate Sustainability Underpins All Innovation

Underlying these technologies is Bracco’s cutting-edge sustainability practices, including implementing reverse osmosis and energy efficiency upgrades at manufacturing sites, as well as partnering with customers for responsible stewardship of iodine.¹ A Platinum Medal from EcoVadis in 2025 places Bracco among the top 1% most sustainable companies worldwide. As a member of the United Nations Global Compact, the company upholds high standards of ecological and operational excellence.¹

“We aim to be a collaborative partner with health systems to manage their healthcare costs, give them a comprehensive portfolio of our products, and meet their environmental goals and sustainability goals,” said Amy King, Director of Sustainability at Bracco Americas.

King highlighted the combined value of Bracco’s MR portfolio, where patients receive half the Gd dose, administered by a syringeless injector with images boosted with AI software. “This means that less gadolinium is mined from the earth, less is injected to the patient, and less is excreted back into our local environments. When it’s delivered with a syringeless, rapid exchange injector, that improves workload and eliminates plastic syringes. And images can be amplified with our AI software to deliver up to two times the image quality. Together, all of that optimizes the use of natural resources while delivering optimal image enhancement,” she said.

These efforts are inspiring sustainability beyond the MR suite. King is helping lead a broader initiative around iodine stewardship in CT – an area where rapid growth is stressing global supply. “We want to support clinicians in using the most appropriate amount so there’s more to go around of this limited resource,” she said.

As RSNA 2025 brings these advances into focus, Bracco’s vision becomes clear: meaningful progress comes from integrating innovation, education and sustainability. From next-generation MR technologies to immersive learning experiences and environmentally responsible practices, Bracco is redefining what it means to support clinicians, enhance patient care and protect resources.

Booth #1911/p>

1. Max 3 Instructions for Use. ulrich medical. November 20, 2025.
2. Data on file. Over 80 Active Accredited Programs. Bracco Diagnostics Inc.; OCT 2024
3. Data on file. Over $1.4M Invested in Medical Education Grants. Bracco Diagnostics Inc.; DEC. 2024.<
4. Data on file. Three Million Doses. Bracco Diagnostics Inc.; September 2025.
5. Data on file. No. of Accounts. Bracco Diagnostics Inc.; September 2025.<
6. VUEWAY® (gadopiclenol) solution for injection, intravenous use. Full Prescribing Information and Patient Medication Guide. Princeton, NJ: Bracco Diagnostics Inc.; March 2025.
7. Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and safety of gadopiclenol for contrast-enhanced MRI of the central nervous system: the PICTURE randomized clinical trial. Invest Radiol. 2023 May;58(5):307-313.
8. Dekker HM, Stroomberg GJ, Van der Molen AJ, Prokop M. Review of strategies to reduce the contamination of the water environment by gadolinium-based contrast agents. Insights Imaging. 2024 Feb 27;15(1):62. doi: 10.1186/s13244-024-01626-7. PMID: 38411847; PMCID: PMC10899148.
9. Please refer to the AiMIFY User Manual for full safety and use information.

VUEWAY^® (gadopiclenol) injection for intravenous use

Dosage Forms

 

VUEWAY^® is available in single-dose vials, single-dose prefilled syringes, and an imaging bulk package.

The VUEWAY Imaging Bulk Package is used for dispensing multiple single doses of gadopiclenol injection for multiple patients, using an automated contrast injection system, or contrast management system approved or cleared for use with this contrast agent in this Imaging Bulk Package. See drug and device labeling for information on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use.

Indications

VUEWAY injection is indicated in adults and children aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:

• the central nervous system (brain, spine, and associated tissues),
• the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

IMPORTANT SAFETY INFORMATION

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. VUEWAY is not approved for intrathecal use.

NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

The risk for NSF appears highest among patients with:

• Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m²), or
• Acute kidney injury.

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindications

VUEWAY injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY.

Warnings and Precautions

There are risks associated with intrathecal use of GBCAs that can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of VUEWAY have not been established with intrathecal use and VUEWAY is not approved for intrathecal use.

Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients with chronic, severe kidney disease as well as patients with acute kidney injury. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.

Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration.

Gadolinium retention can be for months or years in several organs after administration. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver and spleen). Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible.

>Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The risk of acute kidney injury may increase with increasing dose of the contrast agent.

Extravasation and injection site reactions can occur with administration of VUEWAY. Ensure catheter and venous patency before the injection of VUEWAY.

VUEWAY may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when VUEWAY MRI scans are interpreted without a companion non-contrast MRI scan.

The most common adverse reactions (incidence ≥ 0.5%) are injection site pain (0.7%), and headache (0.7%).

POST-MARKETING EVENTS

The following adverse reactions have been identified during postmarketing use of GBCAs.

Gastrointestinal Disorders: Acute pancreatitis with onset within 48 hours after GBCA administration

Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information for VUEWAY (gadopiclenol) solution for injection including BOXED WARNING on Nephrogenic Systemic Fibrosis.

Manufactured for Bracco Diagnostics Inc. by Liebel-Flarsheim Company LLC - Raleigh, NC, USA 27616.

VUEWAY is a registered trademark of Bracco Imaging S.p.A.

© 2025 Bracco Diagnostics Inc. All Rights Reserved.

ulricheasyINJECT Max 3^™ (the Bracco-branded Max 3^™, a Rapid Exchange and Syringeless MR Injector System) is distributed by Bracco Diagnostics Inc.

Indications for use

ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:

• Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
• Gadopiclenol Injection in SD container or IBP
• Gadobenate dimeglumine Injection in SD container
• Gadoterate meglumine Injection in SD container

Easy-Click-Cassette – flex Max 3 is used for a maximum time of twenty-four (24) hours or a maximum of 96 bottles of contrast media, whichever comes first.

Use time expiration per SD container is a maximum of four (4) hours, unless otherwise stated by the contrast media labeling.

Use time expiration per IBP or saline container is a maximum of twenty-four (24) hours, unless otherwise stated by the media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulricheasyINJECT Max 3 (XD 10180) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for high-pressure angiography.

Contraindications

The ulricheasyINJECT Max 3 injectors are not intended for the administration of contrast medium during high-pressure angiography or other applications that do not comply with the intended use>

The injector is not protected against the effects of defibrillation. Before a defibrillator is used, the patient must be disconnected from ulricheasyINJECT Max 3 injector.

Do not add any disposables (i.e. connector tubing or valves) to the ulricheasyINJECT Max 3 disposables or in conjunction with the patient tubing that are not provided by ulrich medical.

No valves or other connectors may be placed in-line between the patient tubing and the patient cannula. The disposables identified in this IFU are designed, manufactured, and tested for connection with cannulas for pressure injections.

Do not use ulricheasyINJECT Max 3 injectors with any other contrast media (other than those described in this IFU). Any other contrast media are inappropriate and should not be used.

Do not operate the injector and terminal, including any accessories, in potentially explosive atmospheres or in the vicinity of combustible materials (especially anesthetic drugs, detergents, and oxygen-enriched environments).

ulricheasyINJECT Max 3 is manufactured by ulrich GmbH & Co. KG.

ulrich medical is a registered trademark of GmbH & Co. KG.

ulricheasyINJECT Max 3 is a trademark of ulrich GmbH & Co. KG.

ulricheasyINJECT Max 3 is distributed as the Bracco-branded Max 3, a Rapid Exchange and Syringeless MR Injector System, by Bracco Diagnostics Inc.; 510 Carnegie Center, Suite 300, Princeton, NJ 08540 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269); Scientific Information: 1-800-257-5181 (Option 2); Website: https://smartinject.com/max3/

All other trademarks and registered trademarks are the property of their respective owners.

© 2025 Bracco Diagnostics Inc. All Rights Reserved.

AiMIFY^™ Software

Indications for Use

AiMIFY is an image processing software that can be used for image enhancement in MRI images. It can be used to increase contrast-to-noise ratio (CNR), contrast enhancement (CEP), and lesion-to-brain ratio (LBR) of enhancing tissue in brain MRI images acquired with a gadolinium-based contrast agent. It is intended to enhance MRI images acquired using standard approved dosage per the contrast agent’s instructions for use.

Cautions

AiMIFY-enhanced images should not be used alone to assist patient diagnosis. The standard post-contrast image must always be reviewed first before using AiMIFY-enhanced images for patient diagnosis.

Please be aware that AiMIFY is not intended for artifact reduction, such as metal artifact and motion artifact. Enhanced images may have similar artifacts as input images.

AiMIFY may enhance intensity differences between pre-and post-contrast images that are caused by 1. registration errors between the sequences or 2. image artifacts in either sequence.

AiMIFY may enhance vessel conspicuity more than standard acquired post-contrast images. In cases where vessel conspicuity interferes with or delays diagnosis, the standard post-contrast image should be used for adjudication.<

AiMIFY-enhanced images may contain false lesions due to enhancement of image quality issues in either input sequences, due to being introduced by the AiMIFY algorithm, or both. The standard post-contrast image should be used to rule out false lesions.

Please be aware that AiMIFY has only been trained and tested on head MRI for contrast enhancement. Using the AiMIFY software in other anatomies or use cases not defined in this user manual could result in unknown image enhancement performance.

The internal morphology of tissue in input sequences have been tested to be moderately preserved by AiMIFY processing both for lesion tissue and parenchyma tissue. Internal morphology may appear to be missing due to window leveling of the image, and can be obtained by adjusting the window levels.

Please be aware that AiMIFY is intended for use only with standard of care quality images. Standard approved dose contrast images should be acquired per the contrast agent’s instructions for use. The standard of care should not be adjusted in preparation for using AiMIFY.

Please be aware that AiMIFY should not be used for acquiring stat scans or emergent scans, as image processing time may delay diagnosis.

Standard approved dose contrast images should be acquired per the contrast agent’s instructions for use. AiMIFY-enhanced images are not fully equivalent to post-contrast images acquired with a higher than recommended actual dosage of contrast. However, the high-dose-like appearance of AiMIFY-enhanced images offers a potentially safer alternative to actually acquiring post-contrast images beyond standard dosing.

Contraindications

AiMIFY is an image processing software that inherently doesn’t cause harm to patients of any subpopulation. However, gadolinium-based contrast agents are associated with contraindications, precautions, and warnings for certain subpopulations. Strictly follow the gadolinium-based contrast agent’s instructions for use, including but not limited to contraindicated patient populations, prior to processing with AiMIFY.

Limitations

AiMIFY has been trained and tested using a diverse DICOM image dataset collected from different MR imaging applications at 0.3T, 1.5T, and 3.0T, including:

• T1 weighted imaging for pre and post-contrast brain scans obtained with gadolinium-based contrast agents in 2D sequences, such as fluid-attenuated inversion recovery (FLAIR) and fast spin echo (FSE).
• T1 weighted imaging for pre and post-contrast brain scans obtained with gadolinium-based contrast agents in 3D sequences, such as BRAin VOlume (BRAVO) inversion-recovery-prep fast split echo (SPGR) and Magnetization Prepared Rapid Gradient Echo (MPRAGE).
• Acquisition in axial, coronal, and sagittal orientations.
• Images acquired with GE Medical Systems, Philips Medical Systems, Siemens Healthineers, and Hitachi scanners (see separate Scanner List for models).
• Images (for performance testing) spanning a variety of pathologies including patients with Cerebritis, Glioma, Inflammation, Lymphoma, Meningioma, Metastatic lesions, Multiple sclerosis, Neuritis, other tumor-related lesions (e.g., resection/radiation necrosis / suspected cyst / etc.), and other abnormalities.
• Patients aged 7 to 86 years old with an even distribution of females and males in the test dataset.
• Lesions in the dataset were small (<1 cc) and large (>1 cc).

Any imaging sequences/applications outside the above list may result in prolonged processing time and/or unreasonable results.

AiMIFY is manufactured for Bracco Diagnostics Inc. by Subtle Medical Inc. – Menlo Park, CA, USA 94025.

AiMIFY is a trademark of Bracco Imaging S.p.A.