Quibim has launched QP-Breast®, the first CE- and UKCA-marked artificial intelligence solution in Europe and the UK designed to detect breast cancer on magnetic resonance imaging (MRI), helping radiologists identify suspicious lesions and streamline breast MRI interpretation.
The new AI-powered decision-support tool automatically detects lesions suspected of being breast cancer on breast MRI scans and generates structured reports that integrate into existing hospital workflows. The company says the solution is intended to help radiologists improve reading efficiency while supporting consistent clinical decision-making.
Growing demand in breast imaging
Breast cancer remains the world's most commonly diagnosed cancer among women, with around 2.3 million new cases reported annually. As the use of MRI expands for screening high-risk women and patients with dense breast tissue, healthcare systems are facing increasing pressure from rising imaging volumes, workforce shortages and growing demand for specialist radiology expertise.
According to the BI-RADS® v2025 Manual, up to four out of five breast lesions undergoing biopsy are ultimately found to be benign, highlighting the need for tools that can support more accurate assessment and reduce unnecessary procedures.
Key capabilities of QP-Breast®
QP-Breast® is designed to assist radiologists during breast MRI interpretation by automatically highlighting suspicious areas and providing structured reports containing lesion size, volume, location and estimated likelihood of malignancy. Biopsy results were used as the reference standard, and the software can be used for both screening and diagnostic breast MRI examinations.
The solution integrates directly into existing hospital IT systems, allowing deployment without disrupting established clinical workflows.
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."
Regulatory approval and availability
QP-Breast® has received CE marking under the EU Medical Device Regulation (MDR 2017/745) as a Class IIb medical device and UKCA marking as a Class IIa medical device. The software is now available across Europe and the UK for use by hospitals, specialist imaging centres and breast screening programmes.
The launch expands Quibim's portfolio of AI-powered imaging solutions, following its QP Prostate software, which is CE and UKCA marked and has also received FDA 510(k) clearance.
Source: Quibim
