EMA Breakthrough Device designation for CancerScan Digital Twin System

The CancerScan Digital Twin System, currently being developed within the EU-funded CancerScan project, has received EMA Breakthrough Device designation and will advance to structured expert guidance on its clinical and regulatory development pathway.

This designation represents an important milestone in the system’s regulatory and clinical development and recognises its potential to address a significant unmet medical need in pancreatic cancer treatment.

The designation was secured by Neovivum CEO Igor Balaž and Irena Milobratović, founder and CEO of Indaea and external advisor to Neovivum. Together, they developed and presented the case demonstrating the severity of the unmet clinical need, the first-in-class technological approach of the CancerScan Digital Twin System, and its potential for meaningful clinical impact.

Igor led the development of the breakthrough case, while Irena, as a certified Regulatory Affairs Professional, provided the regulatory expertise needed to navigate the EU regulatory landscape and shape the submission to the EMA Expert Panel. Their combined work was solely responsible for securing the designation.

We would especially like to thank Irena for her expertise, commitment, and invaluable support throughout this process. Her contribution as Neovivum’s external advisor was instrumental in preparing a strong and carefully developed submission and reaching this important milestone.

For further information about the designation, Igor’s and Irena’s work behind the successful submission, and the next steps for CancerScan, read the full article on the CancerScan project website.