Quibim has launched QP-Breast®, an AI-powered decision-support tool that automatically detects lesions suspicious for breast cancer on MRI, marking the first such tool to receive both CE and UKCA marking in Europe and the UK. The device is CE marked under EU MDR 2017/745 as Class IIb and UKCA marked as Class IIa.
QP-Breast® assists radiologists by highlighting suspicious areas and generating structured reports detailing lesion size, volume, location, and likelihood of malignancy, integrating directly into existing hospital systems. The tool is designed for both screening and diagnostic breast MRI, aimed at hospitals, screening programmes, and specialist imaging centres.
The launch responds to rising demand on radiology services: breast cancer remains the most commonly diagnosed cancer in women globally, with 2.3 million new cases annually, while up to four in five biopsied lesions turn out not to be cancer, driving unnecessary procedures and cost.
QP-Breast® follows Quibim's flagship QP-Prostate®, which holds CE, UKCA, and FDA 510(k) clearance. More than 470 sites worldwide currently use Quibim's imaging products.
