Quibim Introduces CE-Marked Tool to Detect Breast Cancer Through MRI

The European Union and United Kingdom have gained access to Quibim’s QP-Breast artificial intelligence (AI) tool that detects breast cancer using magnetic resonance imaging, which automatically identifies suspected lesions on breast MRI.

QP-Breast helps radiologists interpret breast MRI studies by accurately detecting 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 annually. The total continues to rise, with global incidence expected to increase significantly over the next several 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 four out of five 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 and consistently and improve confidence in decision-making.  

“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,” Quibim CEO Dr. Ángel Alberich-Bayarri said. “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.” 

QP-Breast is a decision-support tool that enhances breast MRI interpretation by: 

• Highlighting suspicious areas automatically, helping radiologists spot potential cancers faster  
• Providing clear, user-friendly reports, including lesion size, volume, location, and the likelihood of malignancy 
• Its suitability for any clinically indicated MRI, both screening and diagnostic. Biopsies have traditionally been used as ground truth.
• Integrating directly into existing hospital systems, with no disruption to workflows 
• Its 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 U.K. regulatory frameworks. The solution is available across Europe and the United Kingdom for use in both screening and diagnostic breast MRI, targeting hospitals, screening programs, and specialist imaging centers. 

The launch follows Quibim’s flagship QP Prostate tool, which is CE- and UKCA-marked and has also received U.S. Food and Drug Administration 510(k) clearance. QP Prostate helps radiologists detect up to 90% of prostate cancer cases.  

Quibim designs tools that unlock imaging data to improve patient outcomes. With offices in New York, Dallas, Cambridge (U.K.), Valencia, Madrid, and Barcelona (Spain), the company was born from the ambition of turning imaging into a catalyst for precision health. Quibim claims to lead the forefront of imaging biomarkers research in life sciences, pioneering the development of advanced algorithms that transform imaging data into actionable predictions in oncology, immunology, and neurology. The company leverages the capabilities of MRI, computed tomography, and PET imaging to create regulatory-cleared medical devices that are integrated into clinical workflows. More than 470 sites globally use Quibim products. 

* BI-RADS v2025 Manual.