GE HealthCare Expands Contrast Media Portfolio with Launch of MRI Agent Pixxoscan (gadobutrol)
27.4.2023 09:00:00 EEST | Business Wire | Press release
GE HealthCare has today announced the launch of Pixxoscan (gadobutrol), its macrocyclic, non-ionic Magnetic Resonance Imaging (MRI) gadolinium-based contrast agent (GBCA). Pixxoscan has been reviewed using a regulatory decentralized procedure (DCP) with marketing authorization already in place in Austria and pending approval, will be introduced to a number of European countries in 2023.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230426005641/en/
Enhanced Magnetic Resonance (MR) procedure with cardiac scan images (Photo: Business Wire)
It has been reviewed as having the same qualitative and quantitative composition in active substance and excipients, and the same pharmaceutical form, as the reference product, Gadovist.
Pixxoscan facilitates visualization of abnormal structures or lesions and helps in the differentiation between healthy and pathological tissue. In line with the reference product, Gadovist, Pixxoscan (gadobutrol) is indicated for use in adults, adolescents, and children of all ages (including term neonates) for contrast enhancement in cranial and spinal MRI and magnetic resonance angiography. It is also indicated for whole body imaging, including liver and kidneys in patients with high suspicion or evidence of having focal lesions to classify them as benign or malignant.
Gadobutrol has a high relaxivity which helps enhance detection, delineation and characterization in MRI across its range of indications. It is also formulated at twice the concentration of gadolinium ions, reducing injection volume by half compared to other GBCAs, providing a tighter bolus. Its cage-like macrocyclic chelate, which encloses the gadolinium, provides high kinetic stability.
Pixxoscan adds to GE HealthCare’s MRI contrast media portfolio which includes macrocyclic Clariscan (gadoteric acid) as well as Rapiscan, used in stress cardiac MR to aid diagnosis of coronary artery disease and offering an alternative for patients who cannot exercise. The availability of Pixxoscan will give radiology departments greater access to agents supporting a broad range of MRI procedures, helping them in personalizing care for patients.
Dr Gianluca Pontone, Director of Perioperative Cardiology and Cardiovascular Imaging Department, Monzino Cardiology Center, Milan, Italy, said: “GE HealthCare continues to expand its range of products and Pixxoscan sitting alongside cardiac stress agent, Rapiscan, is welcome news. This gives me, as a cardiologist, the products I need to aid in making timely diagnoses for patients with suspected coronary artery disease.”
Mark Hibberd, Chief Medical Officer, GE HealthCare Pharmaceutical Diagnostics, said: “This extension to our portfolio means, we will be able to offer two leading macrocyclic molecules – Clariscan (gadoteric acid) and Pixxoscan (gadobutrol) - to our customers in a number of European countries, offering radiology departments even more choice to suit their diagnostic needs. We continue to innovate and invest in our contrast media portfolio to deliver for healthcare professionals and patients and to meet future demand.”
Pixxoscan (gadobutrol) offers a wide range of packaging encompassing glass vials, ready-assembled plastic prefilled syringes and larger volume +PLUSPAK polypropylene bottles. GE HealthCare’s +PLUSPAK plastic packaging, using flip-top lids, helps eliminate risk of, and downtime from, broken glass and ring-pull injuries. +PLUSPAK also provides more choice for customers and helps them reduce their costs and environmental impact.
As with all GE HealthCare contrast agents, Pixxoscan will be produced in compliance with current Good Manufacturing Practices (cGMP) - with rigorous testing at our primary and secondary manufacturing sites in Norway to ensure high quality. Once approved, it will then be labelled and packed for onward shipping via our standard distribution network to local markets.
GE HealthCare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. For more than 40 years, GE HealthCare imaging agents have been routinely used across MRI, X-ray/CT and ultrasound to enhance clinical images and support diagnosis.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are an $18.3 billion business with 50,000 employees working to create a world where healthcare has no limits.
Follow us on Facebook, LinkedIn, Twitter, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230426005641/en/
Contact information
GE HealthCare Media Contact:
Debbie Leven
M +44 778 545 6999
Debbie.Leven@ge.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
VerSprite Launches Fork and Knife: AI-Driven Threat Modeling and Adversarial Testing Built for the Speed of Modern Software27.6.2026 00:28:00 EEST | Press release
VerSprite, a global leader in risk-based threat modeling and the firm behind the PASTA (Process for Attack Simulation and Threat Analysis) methodology, today announced the general availability of Fork (www.forktm.com), a continuous application threat modeling platform, alongside Knife, an AI-led, human-on-the-loop adversarial testing platform for web applications and web API endpoints. Together, the two products operationalize a new model for product security—one where applications are securely designed, continuously modeled, and actively tested as part of the build process itself. The launch addresses a problem every security leader knows but few tools have solved: threat modeling is essential, never more so than in an AI-driven era, yet it has remained slow, manual, and anchored to frameworks designed for a different threat landscape. The problem: threat modeling matters more than ever—and most tools are stuck in 2005 For two decades, application threat modeling has leaned heavily on
Venture Global Announces Closing of $1.5 Billion Senior Secured Vessel Financing Facility26.6.2026 23:30:00 EEST | Press release
Venture Global, Inc. (NYSE: VG) announced today that its wholly-owned subsidiary, Venture Global Shipping Holdings, LLC (“VGSH”), has entered into a Credit and Guaranty Agreement providing for a senior secured term loan facility (the “Facility”) in an aggregate principal amount of up to $1,500,000,000. The Facility will mature on June 26, 2032. Deutsche Bank and ING acted as coordinating lead arrangers for the Facility. ING also serves as facility agent and security trustee. VGSH intends to use the net proceeds from the Facility for general corporate purposes, including to reimburse Venture Global LNG, Inc. for payments previously made by it or its affiliates in connection with the acquisition of nine LNG carriers, funding certain reserve accounts, and paying transaction fees and expenses. About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (“LNG”) with over 100 MTPA of capacity in production, construction, or development. Ven
Capco Recognized by OpenAI for Innovation and Responsible AI Leadership26.6.2026 21:00:00 EEST | Press release
Global management and technology consultancy Capco, a Wipro company,has been recognized by OpenAI for both AI innovation and responsible AI leadership. Capco received the AI Governance & Risk Excellence Award at the recent OpenAI Partner Summit 2026 in San Francisco, highlighting Capco’s ability to deliver enterprise-grade AI outcomes in highly regulated environments. The award recognizes Capco’s expert advantage when helping financial services and energy organizations to scale AI with confidence, balancing innovation with strong governance to reduce risk, strengthen compliance and improve customer outcomes. This award follows Capco winning the OpenAI Codex Hackathon, where its UK AI Lab competed against more than 30 teams and over 100 participants from across the OpenAI partner ecosystem. Capco's winning entry Sentra – a consulting-led, AI-powered retail banking solution – uses digital twin technology to identify vulnerable customers and recommend explainable next-best actions for fro
Incyte Announces Positive CHMP Opinion for Opzelura ® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 14:30:00 EEST | Press release
Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. “AD is a chronic skin condition that can have a significant impact on daily life. The positive CHMP opinion for Opzelura marks meaningful progress toward bringing the first non-steroidal topical JAK treatment option to adults in Europe with moderate AD for whom standard topical therapies have failed,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved by the European Commission, Opzelura could help address an important gap for patients who have limited treatment options when TCSs and TCIs are inadequate or inappropriate.” The positive CHMP o
Datroway ® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 14:00:00 EEST | Press release
Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02phase 3 trial, which werepresented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In TROPION-Breast02, Datroway demonstrated a
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom