The CE- and UKCA-marked software automatically highlights suspicious lesions and generates structured findings for screening and diagnostic exams.
Quibim, specializing in precision imaging and artificial intelligence (AI) solutions, announced the European and UK launch of QP-Breast, its CE and UKCA-marked AI tool that detects breast cancer using magnetic resonance imaging (MRI) and automatically identifies suspected lesions on breast MRI.
QP-Breast is designed to assist radiologists during the interpretation of breast MRI studies by providing accurate detection of lesions suspicious for breast cancer and generating 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, according to a release from Quibim.
Rising scan volumes, workforce shortages and variation in how images are interpreted can all delay diagnosis or lead to unnecessary follow-up procedures, the company states in the release, noting that 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, 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. 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,” says Dr Ángel Alberich-Bayarri, CEO of Quibim, in a release.
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
- Provides 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 into existing hospital systems
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.
This follows its flagship QP Prostate tool, which is CE and UKCA-marked and has also received 510(k) clearance from the US Food and Drug Administration, which helps radiologists detect up to 90% of prostate cancer cases, according to the company.
