FDA Approves Low-Dose MRI Contrast for Infants, Accepts Bayer Application, Grants AI X-ray Breakthrough

Bracco announced that the U.S. Food and Drug Administration has approved the extension of the current Vueway (gadopiclenol) solution for injection, intravenous use, for use in neonates and infants. Vueway injection is a macrocyclic gadolinium-based contrast agent (GBCA) that provides effective contrast enhancement at half the gadolinium dose (0.05 mmol/kg) compared with other macrocyclic GBCAs approved in the United States (0.1 mmol/kg), helping reduce cumulative gadolinium exposure without compromising image quality.

Reducing gadolinium exposure while maintaining diagnostic performance is important for all patients undergoing contrast-enhanced MRI, and is particularly critical in neonates and infants, whose brains and body tissues are still developing. Clinical guidance from radiology societies emphasizes the use of the lowest effective GBCA dose when contrast-enhanced imaging is required.

The FDA approval was based on data from study GDX-44-015, which evaluated the safety and efficacy of Vueway injection in pediatric patients. Gadopiclenol was first approved by the FDA in September 2022 and obtained EU approval in December 2023 for use in adult patients and in pediatric patients aged 2 years and older. In January 2026, gadopiclenol received EU approval expanding its approved indications to include neonates and infants.

More than 3.5 million doses of Vueway injection have been administered across approximately 900 customer sites in the U.S., reflecting growing clinical adoption and patient preference for lower-dose contrast agents. Vueway injection is a highly stable macrocyclic GBCA with the highest longitudinal relaxivity (r1) values among currently approved GBCAs. Large, multicenter clinical studies have demonstrated that Vueway injection provides comparable diagnostic efficacy at half the gadolinium dose of gadobutrol, a GBCA widely used in clinical practice.

In a separate development, Bayer announced that a New Drug Application (NDA) for its investigational contrast agent gadoquatrane has been accepted for review by the U.S. Food and Drug Administration. The NDA for gadoquatrane has been filed for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients, including neonates.

If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent available in the U.S. The submitted dose is 0.04 mmol gadolinium per kilogram body weight, corresponding to a 60 percent reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.

The submission of gadoquatrane to the U.S. FDA is based on positive data from the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane in adult and pediatric patients globally. The pivotal QUANTI clinical development program investigated gadoquatrane at a dose of 0.04 mmol Gd/kg body weight. QUANTI consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies – QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) – as well as the QUANTI Pediatric study. In total, 808 patients in 15 countries participated in the program.

The QUANTI study results show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that observed in adults. The observed safety profile in adults as well as pediatric patients from birth to < 18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed.

Healthcare authorities in Japan, the European Union and other countries are currently reviewing applications for marketing authorization for gadoquatrane. Approximately 12-18 million contrast-enhanced MRI scans are performed annually in the United States. Since their introduction in 1988, more than 800 million GBCA doses have been administered worldwide, with an estimated 63 million doses in 2023.

Radiology Partners' recently acquired artificial intelligence business, Cognita, has received the Breakthrough Device designation from the U.S. Food and Drug Administration for a key radiograph-related technology. The country's largest imaging group announced the news Thursday, with the decision applying to its Cognita Chest X-ray tool across multiple clinical indications. Rad Partners believes this is the industry's first generative vision-language model—AI that combines computed vision and large language models to decipher content—to assist radiologist in interpreting X-rays.

Based on public information, the AI tool also is one of the first such solutions to earn this label from the FDA. The Breakthrough Program helps to expedite the review of new medical devices that address critical diseases or conditions.

Cognita CXR applies proprietary AI to interpret radiographs and draft preliminary reports for physician review. Different from other AI that focuses on individual findings, the model generates comprehensive preliminary findings that are fully integrated into existing workflows. Radiologists are then able to review and finalize the findings, Rad Partners noted.

Early internal validation shows that participating Rad Partners radiologists using Cognita CXR achieved enhanced detection of up to 16% to 65% for certain findings. The AI program also has the potential to boost average interpretation efficiency for participating radiologists by 18%. Breakthrough Device designation will allow Cognita to collaborate closely with the FDA to help bring this technology to the U.S. market.

Cognita and RP also are working to develop solutions that assist radiologists in interpreting X-rays and 3D CT imaging across all anatomies. Rad Partners first launched its Mosaic division in July and acquired Cognita, which was founded at Stanford University, for $80 million in November. Based in Nashville, Tennessee, Rad Partners employs approximately 4,000 physicians, handles 55 million imaging studies annually, and is partially backed by outside investors.