CE Approval for NUCLARITY: Safer & Faster PET Imaging

The young Ghent-based company Nuclivision is entering the European market with NUCLARITY, a medical software that makes PET scans in nuclear medicine faster and safer. PET scans use small amounts of radioactive material to enable early diagnosis in oncology and dementia. Since the method involves injection of radioactive tracers—often radioactive glucose—it brings a certain level of radiation exposure. This makes dose reduction especially relevant in pediatric patients and repeated imaging scenarios.

“NUCLARITY allows for up to 50% reduction in the combination of administered dose and scan time,” says Maarten Larmuseau, co-founder and CEO of Nuclivision.“This reduction lowers the burden on patients, increases scanner efficiency, and makes the workflow more scalable in the context of rising PET demand. It enables faster scheduling of scans, better utilization of scanners, and a structural reduction of radiation exposure in nuclear medicine. A clear win-win for both physicians and patients.”

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Operating from the Wintercircus startup hub in Ghent, Belgium, the growing team can now officially access the European market thanks to the CE marking of NUCLARITY as a class IIa medical device. With this milestone, Nuclivision joins a select group of Belgian companies to have successfully obtained approval for an AI application in this risk class—with an exceptionally small team. The company is also targeting the U.S. market within the next year. Earlier in 2025, Nuclivision secured five million euros in growth capital from investors including HERAN Partners, imec.istart Future Fund, and the impact fund LUMO Labs. These funds will be used to commercialize NUCLARITY and to furtherd develop AI-driven software in nuclear medicine.

“Our initial focus is on safe and efficient imaging,” Larmuseau explains. “But we plan to rapidly move toward patient selection and therapy prediction, particularly in the context of theranostic applications.” Theranostics, also known as radioligand therapy, is a domain within nuclear medicine where a single radioactive compound is used for both diagnosis and treatment. One example already in clinical use is lutetium therapy for prostate cancer or neuroendocrine tumors.

The number of PET scans is growing by more than 15% annually. This increase, combined with rising clinical complexity and a shortage of nuclear medicine professionals, is putting hospitals under pressure. According to Alex Maes, Nuclivision advisor and physician-professor at AZ Groeninge and KU Leuven, the need for smart software has become indispensable. “We already see a strong rise of AI in radiology, in CT and MRI. Nuclear medicine will follow—but only if the underlying image quality is robust and the models are sufficiently well-trained. That’s where Nuclivision is uniquely positioned.”
Belgium has a strong ecosystem in theranostics, with key players such as IBA, Trasis, SCK CEN, and Pantera. Major international pharmaceutical companies like Novartis and Telix Pharmaceuticals are also investing heavily in the field. Once these therapies demonstrate clinical effectiveness and gain approval, they offer the potential for more targeted and less toxic alternatives to traditional chemotherapy or radiotherapy. Nuclivision positions itself as a software partner in this domain, with a clear focus on clinical value, scalability, and healthcare system sustainability.

CEO Larmuseau concludes: “By starting with safe and efficient imaging, we’re creating a strong foundation to train AI models for patient selection, response prediction, and treatment decisions. With PET scan volumes increasing by over 15% annually, the growing clinical burden and shortage of nuclear medicine professionals make intelligent software essential to optimize workflows and safeguard access to advanced imaging.”