Paris, April 2, 2026 – VisioCyt® Bladder, an innovative non-invasive diagnostic solution for bladder cancer, is now covered under the national RIHN 2.0 program, following a favorable joint assessment by the French National Authority for Health (HAS) and the Directorate General for Health (DGS).
An innovative, non-invasive solution, now covered
VisioCyt® Bladder is a solution dedicated to the diagnosis and monitoring of non-muscle-invasive bladder tumors (NMIBC), based on artificial intelligence and cytological image analysis. Performed using a simple urine sample, this test represents an alternative to cystoscopy, the reference examination, which is often poorly tolerated by patients.
Its inclusion in RIHN 2.0 marks a decisive step in access to an innovation that could significantly ease the care pathway, reduce the need for invasive procedures, and improve patients’ quality of life.
Coverage terms and conditions
VisioCyt® Bladder is 100% covered, effective immediately, through real-world data collection linked to the NMIBC registry managed by the French Association of Urology (AFU) within participating healthcare institutions. The CE IVDR-certified test may also be prescribed in routine practice, with a patient co-payment of €253.
Healthcare institutions wishing to offer VisioCyt® Bladder within the NMIBC registry must establish an agreement with a partner pathology laboratory. To implement this system, teams may contact [email protected]
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Any updates regarding coverage conditions will be communicated.
A rigorous real-world evaluation
This temporary coverage is based on structured collection of clinical and medico-economic data, through the TVNIM-AFU registry. The aim is to assess the performance of VisioCyt® Bladder in routine practice, particularly by comparing its sensitivity and its negative predictive value with those of cystoscopy.
These data are intended to support ongoing discussions with health authorities, with the goal of evolving coverage conditions and enabling broader access to the test for a larger number of patients.
A step toward standard reimbursement
The results from data collection will help demonstrate the medical and economic benefits of the test, with a view to achieving standard reimbursement. The objective is to firmly establish VisioCyt® Bladder in clinical practice and improve patients’ comfort and daily lives.
A breakthrough welcomed by healthcare professionals and patients
Professor Yann Neuzillet, urologist and coordinator of the AFU NMIBC registry, states:
“Coverage of VisioCyt® Bladder is an important step forward. Within the RIHN 2.0 framework, we will be able to document its value in real-life conditions. Ultimately, this solution could reduce repeated cystoscopies, which are experienced as a burden by patients.”
Lori Funk-Cirefice, President of the patient association Cancer Vessie France, adds:
“This is excellent news for patients. This coverage allows broader access to a long-awaited innovation. Fewer invasive procedures, less stress: depending on the upcoming results of the TVNIM-AFU registry, we can hope for real progress in bladder cancer monitoring.”
Acknowledgements
We thank all healthcare professionals, institutional partners, and patient associations for their commitment to this innovation. Special recognition goes to the VitaDX teams, whose dedication and rigor were decisive, as well as to Rweality for its support in submitting the dossier.
About VitaDX International
Founded in 2015, VitaDX develops and markets cancer diagnostic solutions combining image analysis and artificial intelligence applied to cytology through its patented VisioCyt® technology. Its mission is to develop innovative, high-performance solutions with a significant impact on healthcare systems for the benefit of as many patients as possible.
After several years of development and a prospective multicenter clinical study, its first solution, VisioCyt® Bladder (CE IVDR marked), enables the diagnosis and monitoring of bladder cancer from a simple urine sample.
Other devices are currently under development, particularly for bladder cancer screening and thyroid cancer diagnosis.
To learn more about VitaDX and VisioCyt® Bladder: www.vitadx.com
Press contact:
Communication & Marketing – [email protected]
Tel: +33 1 48 87 00 55