Portugal-based CleoCare has launched clinical trials in Portugal and the United States to validate its breast health technology, marking a major milestone in the company’s path toward regulatory approval and commercialization.
The company is developing SenseGlove, a portable home-based medical device designed to complement breast self-examinations and support breast health monitoring.
The clinical studies are being conducted at Hospital da Luz in Portugal and the University of Alabama at Birmingham in the US.
According to CleoCare, breast cancer is the most common malignant tumour among women, around 35% of cases are detected at a late stage, and regular breast self-monitoring is essential for early diagnosis.
According to the company, the trials will generate the clinical evidence needed to evaluate the technology’s ability to support the early detection of breast abnormalities.
CleoCare said the studies will also help strengthen its product, validate its clinical impact and advance its regulatory and market readiness.
The launch of clinical trials in both Portugal and the US reflects the company’s progress from research and product development to international partnerships and real-world clinical validation.
The company said the milestone supports its mission to make breast health monitoring more accessible, proactive and user-centered, while acknowledging the contribution of clinicians, researchers and institutional partners involved in the project.
The system combines a mobile app with the SenseGlove to help women monitor their breast health at home. The app reminds users when it is time for their monthly breast check. During the self-examination, users wear the glove to scan their breasts while its sensors detect changes in the tissue. The app provides step-by-step instructions in real time, showing users where to move the glove and helping them complete the examination correctly.
