Quibim has announced the European and UK launch of QP-Breast, its CE and UKCA-marked AI tool – the first in Europe and the United Kingdom to detect breast cancer using magnetic resonance imaging – which automatically identifies suspected lesions on breast MRI.
QP-Breast assists radiologists during the interpretation of breast MRI studies by providing accurate detection of lesions suspicious for breast cancer and generating clear, user-friendly reports that slot into existing hospital systems.
Breast cancer remains the most commonly diagnosed cancer in women globally, with 2.3 million new cases each year. This figure continues to rise, with global incidence expected to increase significantly over the coming decades. As MRI plays a growing role in screening and diagnosis, particularly for high-risk patients and those with dense breast tissue, radiology teams are under increasing strain.
Rising scan volumes, workforce shortages and variation in how images are interpreted can all delay diagnosis or lead to unnecessary follow-up procedures. In fact, up to 4 out of 5 biopsied breast lesions are not cancer, leading to unnecessary procedures, increased healthcare costs, and added stress for patients.
QP-Breast is designed to ease this burden by helping clinicians read scans more quickly, consistently and improve confidence in decision making.
Dr. Ángel Alberich-Bayarri, CEO of Quibim, said: “Radiology teams are facing growing demand, but resources aren’t keeping pace. QP-Breast is designed to assist clinicians during the interpretation of breast MRI studies by providing accurate detection of lesions suspicious for breast cancer. By automating time-consuming parts of MRI analysis and delivering clear, structured outputs, we’re enabling radiologists to focus on what matters most. That is, making informed decisions and improving their patients’ care.”
Key features of QP-Breast
QP-Breast is a decision-support tool that enhances breast MRI interpretation with the following capabilities:
- Highlights suspicious areas automatically, helping radiologists spot potential cancers faster
- Provides clear, user-friendly reports, including lesion size, volume, location and likelihood of malignancy
- Biopsies have been used as ground truth. Suitable for any clinically indicated MRI, both screening and diagnostic.
- Integrates directly into existing hospital systems, with no disruption to workflows
Regulatory and launch scope
QP-Breast is CE marked under EU MDR 2017/745 as a Class IIb medical device and UKCA marked as a Class IIa medical device, confirming compliance with both European and UK regulatory frameworks. The solution is available across Europe and the United Kingdom for use in both screening and diagnostic breast MRI, targeting hospitals, screening programmes and specialist imaging centres.
The launch reflects Quibim’s commitment to developing AI tools that assist healthcare providers in managing growing demand for imaging, while improving the speed and quality of diagnosis. This follows its flagship QP Prostate tool, which is CE and UKCA marked and has also received 510(k) clearance from the FDA, which helps radiologists detect up to 90% of prostate cancer cases.
