Saving lives with accessible breast screening

Breast cancer screening is inaccessible across most of the world. Mammography infrastructure is expensive, trained radiologists are scarce, and women in low-resource settings often have no affordable way to check for early warning signs.

UE Life Sciences developed iBreastExam: a handheld, radiation-free, battery-powered screening device that detects tissue stiffness variations clinically associated with tumours. They needed a clinical-grade software platform to operate the device, store data, support clinicians in the field, and satisfy FDA requirements for medical device software.

• iOS and Android applications driving the clinical device
• Cloud-based data platform for exam storage, analysis, and longitudinal follow-up
• Clinician dashboards with patient management workflows
• FDA-compliant audit trails, data security, and validated software lifecycle
• Multi-language interfaces for deployment across diverse geographies
• Offline-first architecture for deployments in low-connectivity regions

Medical device software is one of the most demanding environments to engineer for. Every line of code is subject to traceability, validation, and regulatory review.

We partnered with UE Life Sciences' clinical and regulatory teams to embed these requirements into engineering from day one. The platform has evolved across multiple hardware generations and regulatory cycles without losing continuity or backwards compatibility for data collected a decade ago.

iBreastExam has been deployed in community health programmes across the United States, India, Mexico, South Africa, Botswana, Malaysia, and beyond - screening over two million women who would otherwise have had no access to early detection.

The partnership continues. Every major feature, every new market, every regulatory submission has been delivered by the same team Creo assembled at the start.