GE HealthCare Expands Contrast Media Portfolio with Launch of MRI Agent Pixxoscan (gadobutrol)
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
Vertex Announces US FDA Approval of ALYFTREK ™ , a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis20.12.2024 22:46:00 EET | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to ALYFTREK. See below for Important Safety Information, including a Boxed Warning. “ALYFTREK is our fifth CFTR modulator to secure FDA approval and represents another significant milestone in our journey to serially innovate and to improve the lives of people living with cystic fibrosis,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “Our north star for more than 20 years has been to address the underlying cause of cystic fibrosis, treat more people with this disease, and bring more people to normal le
Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non- F508del TRIKAFTA-Responsive Variants20.12.2024 22:35:00 EET | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to TRIKAFTA based on clinical and/or in vitro data. In addition, safety information on liver injury and liver failure has been updated from warnings and precautions to a boxed warning. With this approval, 94 additional non-F508delCFTR mutations have been added to the TRIKAFTA label, and approximately 300 additional people with CF in the U.S. are now eligible for a medicine to treat the underlying cause of their disease for the first time. “Since its first approval in 2019, TRIKAFTA has had a transformative impact on tens of thousands of people living with cystic fibrosis,” sai
HSBC Continental Europe Enters Into a Memorandum of Understanding Regarding Potential Sale of HSBC Assurances Vie (France) to Matmut Société d’Assurance Mutuelle20.12.2024 21:32:00 EET | Press release
Regulatory News: HSBC Continental Europe has signed a Memorandum of Understanding (‘MOU‘) regarding the potential sale of its French life insurance business, HSBC Assurances Vie (France), to Matmut Société d’Assurance Mutuelle (‘Matmut’) (the “Potential Transaction”). HSBC Assurances Vie (France) provides a wide range of life insurance solutions and services, with over 20 billion euros of outstanding assets, net income1 of 77 million euros and a Solvency II ratio of 287% in 2023. As part of the Potential Transaction, HSBC Continental Europe and Matmut would enter into a long-term arrangement for HSBC Global Asset Management (France) to continue to partner with HSBC Assurances Vie (France). HSBC Assurances Vie (France) will continue its existing distribution arrangements. The Potential Transaction would provide customers and employees of HSBC Insurance Life (France) with the opportunity to join one of the leading French mutual insurance groups, which is in full development, and forms pa
Aarhus University: New Global Study Sheds Light on the Learning Crisis: Three Years After COVID-1920.12.2024 14:00:00 EET | Press release
TIMSS 2023 has revealed an alarming global learning crisis exacerbated by the COVID-19 pandemic. Compared to the long term trend in progress in mathematics and science achievement has not only stalled but reversed when taking school closures into account, with the most vulnerable students facing the steepest losses. Key Findings Global Achievement Decline: A 0.11 standard deviation drop in student performance reflects the pandemic's lasting impact. Disproportionate Impact: Low performers, girls, and language minorities faced losses up to twice the average (0.22 standard deviations), deepening existing inequities. Regional Variations: Countries with prolonged school closures and limited remote learning resources experienced the steepest declines. Why This Matters School closures disrupted the education of over one billion children worldwide, with disadvantaged students suffering the most. “The widening gender gap in STEM fields is particularly troubling,” said Christian Kjeldsen, incomi
SBC Medical Group Co., Ltd. Sells Two Subsidiaries20.12.2024 14:00:00 EET | Press release
On December 17, 2024, SBC Medical Group Holdings Incorporated (“SBC Medical”, or the “Company”), announced that its subsidiary, SBC Medical Group Co., Ltd. (hereinafter referred to as "SBCMG"), has decided to sell all shares of its subsidiaries, SBC Kijimadaira Resort Co., Ltd. (hereinafter referred to as "Kijimadaira") and Skynet Academy Co., Ltd. (hereinafter referred to as "SNA"), as outlined below. The decision to sell these subsidiaries was made to concentrate SBCMG's management resources on its core medical services business, in line with its strategy of prioritizing and focusing on key business areas. The subsidiaries being sold operate in the following industries: Kijimadaira: Ski resort operations SNA: Flight training operations The shares will be sold to a company wholly owned by Yoshiyuki Aikawa, the CEO of the Company. Since this transaction constitutes a related party transaction, it was deliberated and approved by the Company’s Board of Directors and Audit Committee. To e
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