WALTHAM, Mass. — CellTivity Scientific, a company focused on point-of-care disease detection, announced that its Van Gogh™ Microscopy System has received CE registration, clearing the device for clinical use and commercial distribution across the European Union.
The CE registration grants the Van Gogh system a Class A IVDR designation, validating its safety, performance, and reliability for use across all biopsy types. The system’s real-time sampling technology, known as Dynamic Cell Imaging™, captures metabolic activity at the point of care to support clinicians during biopsy acquisition. By using light-based imaging to highlight cell shape, size, and activity in a heatmap, the system is designed to help clinicians assess tissue adequacy immediately and improve collaboration with pathology teams.
“Van Gogh gives clinicians immediate clarity on the quality of collected samples, helping reduce nondiagnostic specimens and support a faster path to diagnosis,” said Greg Bowles, CEO of CellTivity Scientific. “Since receiving CE registration in October 2025, CellTivity has initiated early deployments and partner-led introductions across Europe, generating strong initial interest and paving the way for expanded collaboration with leading clinical teams and distribution partners. This is a significant achievement for our team and an important step forward for clinicians and patients across Europe. Van Gogh equips physicians with actionable information at the point of care, and strengthens collaboration with pathology. This milestone reinforces our mission of empowering proceduralists to improve patient outcomes.”
Designed to integrate into existing procedural workflows, the Van Gogh system supports a broad range of biopsy types and clinical environments, including high-volume centers, community hospitals, and facilities adopting advanced technologies such as robotic-assisted bronchoscopy. By providing real-time insight into sample quality, the system aims to help clinicians collect higher-quality tissue and reduce delays that can affect diagnosis and treatment timelines.
“CE Marking for the VanGogh System represents an important milestone in the European market,” said Franco Papa, President and CEO of MOSS, CellTivity Scientific’s European partner responsible for introducing and distributing the system. “Through our strategic partnership with CellTivity Scientific, at this early stage we have already seen strong engagement and promising interest in the utilization from leading physicians and institutions of excellence across Europe, including Italy, Germany, Austria and Slovenia. This allows us to move forward with confidence and confirm our commitment to supporting teams with technology that aligns with evolving workflows.”
Following CE registration, CellTivity has begun expanding the availability of the Van Gogh system across key European markets. The company said it plans to work closely with clinicians, hospitals, and distribution partners to support adoption, training, and integration into diagnostic pathways.
The regulatory clearance also expands CellTivity’s commercial footprint in Europe. CE registration positions the company to enter the European diagnostic market, pursue new partnerships, and advance discussions with hospitals and industry groups as demand grows for point-of-care disease detection technologies.
