Regensight is proud to announce that C4V CHROMO4VIS, the first theranostic device in ophthalmology, has officially received CE certification under the Medical Device Regulation (EU) 2017/745 (MDR).
This major regulatory achievement confirms the device’s compliance with the highest European standards for safety, performance, and quality.
C4V CHROMO4VIS is a groundbreaking innovation in the treatment of keratoconus, integrating real-time molecular imaging with targeted therapy in a single platform. Through theranostics, clinicians can now deliver personalized, predictive, and data-driven treatments, enhancing clinical safety and therapeutic outcomes.
This CE MDR certification marks a turning point in ophthalmic care: precision medicine is no longer a promise: it is a clinical reality available to patients with keratoconus.
This milestone was made possible by the exceptional work of our multidisciplinary team, the collaboration with leading clinical centers, and the support of regulatory partners who shared our vision of responsible innovation.
The future of keratoconus treatment is theranostic-guided!