Bayer’s Ultravist (Iopromide Injection) approved for contrast-enhanced mammography in India

CDSCO has approved an additional indication for Ultravist – Iopromide Contrast Agent by Bayer. It can now be used in Contrast-Enhanced Mammography to visualise known or suspected breast lesions in adults, as an adjunct to mammography and/or ultrasound. This landmark decision marks a significant advancement in breast cancer diagnosis across India

Breast cancer remains one of the most prevalent cancers worldwide, accounting for 11.7 per cent of all cancer cases. In India, it is a leading cause of cancer-related deaths among women. According to the National Cancer Registry Report 2020 there is a significant increase in age-adjusted incidence rates (AAR) of breast cancer across the country on a continuous basis. To combat the higher incidences of breast cancer, increased awareness and accurate diagnosis are important.

Contrast-enhanced mammography (CEM)

Approximately 20 per cent of breast cancers that are present at the time of screening are missed by traditional mammograms. A recent study reports a 22–48 per cent prevalence of dense breasts among women in India. For these women, the greatest challenge is identifying breast lesions, as these can be masked or hidden, leading to delayed diagnosis. Traditional mammography cannot reliably distinguish between benign and malignant lesions, resulting in unnecessary follow-up procedures.

CEM is an emerging modality that addresses many of the clinical, operational, and economic challenges of traditional mammography. It combines the advancement of mammography and intravenous contrast agents for clear visualization of breast neovascularity. The contrast media diffuses across leaky neovascularity and allows detection of tumour tissue. It enables accurate evaluation of tumour size and extent and identifies whether the disease is unifocal, multifocal, multicentric, or bilateral. This enhanced accuracy supports better surgical planning and treatment decisions.

Several studies have demonstrated that it has the accuracy and specificity of breast MRI making it an alternative imaging modality for women with MRI contraindications.

Bridging the gap in CEM with Ultravist

CEM uses an iodine-based contrast medium, which is delivered via a precise injection system. Dual-energy mammographic images acquired after injection yield low-energy images like conventional 2D mammography and high-energy images used for contrast detection. An advanced post-processing software recombines the images and highlights highly vascularised areas. This helps the radiologist to identify, localise and assess the extent of breast lesions.

Ultravist® is Bayer’s iodinated contrast agent that is the first iodinated contrast agent to receive this approval for CEM in India. It has legacy of 40+ years and has existing approvals for CEM in several other countries. It supports consistent visualization of tumour associated neovascularity, helping clinicians make confident diagnostic decisions when clarity matters most. What distinguishes Ultravist® in CEM is not just its performance but its proven reliability, safety, and scalability in real-world practice.

Backed by robust clinical evidence, it provides radiologists with a trusted contrast solution that seamlessly integrates into existing mammography suites. Its superior sensitivity in lesion detection and characterisation within a span of 10 minutes makes it a time-efficient alternative to longer imaging duration of conventional breast MRI.

Rahul Pandey, Country Head Radiology, South Asia at Bayer India, shares, “At Bayer, our commitment “Health for All,” drives us to continuously improve patient access to world-class solutions and enhance the health outcomes for people across India. With our integrated portfolio of modern imaging solutions backed by robust training and hands-on services, we empower clinicians with tools to improve clinical outcomes and optimise workflows.”

See the possible, create the future

At Bayer Radiology, we recognise that everyone has different needs in breast cancer diagnosis and care. We have been committed to offering personalised breast imaging solutions that address the unique needs of every patient.

With our integrated portfolio of modern imaging solutions, we are actively creating a future where women receive timely, confident diagnoses, paving the way for faster intervention and better patient outcomes.

Disclaimer: This content is intended for registered healthcare practitioners in India.

approvalsbreast cancerCDSCOMammographymedtechtechnology
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