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CE approval for Nuclivision software paves the way for safer and faster cancer diagnostics

June 26, 2025 - Ghent (BE)
Ghent-based medtech company Nuclivision launches Nuclarity, a European-approved medical software that makes PET scans faster and safer. Following extensive clinical validation, the company has obtained CE marking as a class IIa medical device for its first product, enabling the growing team to enter the European market.


PET scans are widely used in oncology and for the early detection of dementia, but they involve radiation exposure due to the use of radioactive tracers. Nuclarity enables scans to be performed with only 50% of the usual tracer dose and in a shorter acquisition time, without compromising diagnostic image quality. This not only reduces patient exposure, but also improves efficiency and lowers costs for the hospital. Such dose reduction is particularly valuable in cases where minimizing radiation is critical, such as in pediatric patients or during repeated imaging. The optimal balance between dose and scan time can be tailored to the needs of each hospital.


Earlier this year, Nuclivision raised five million euros in growth capital to commercialize the software and further develop AI-based solutions in nuclear medicine. The company is currently collaborating with centers in Belgium, the Netherlands, France, and Italy. The demand for PET scans is growing by about 15% annually, and theranostics—where a single radioactive compound is used for both diagnosis and therapy—is gaining ground rapidly. Nuclivision aims to position itself as a digital partner supporting nuclear medicine departments in meeting this rising demand.

 

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