France has taken a landmark step in its commitment to early access pathways for diagnostic innovation.
On 5 June 2025, the Haute Autorité de Santé (HAS) published its first formal decision under the renewed RIHN 2.0 framework, approving conditional reimbursement for an AI-assisted digital cytology test, VisioCyt Bladder, for surveillance of non-muscle-invasive bladder cancer (NMIBC) recurrence.
This decision is not just a regulatory milestone, it is a signal to the diagnostics industry that artificial intelligence tools can now be funded in France, provided they are paired with rigorous real-world evidence (RWE) plans.
Originally launched as a pilot in 2020, the RIHN (Référentiel des Innovations Hors Nomenclature) framework was designed to support innovative in-vitro diagnostics (IVDs) not yet included in France’s NABM (Nomenclature des Actes de Biologie Médicale).
The updated RIHN 2.0, formalised in November 2024, provides:
- A structured submission process for IVDs not listed in NABM;
- Temporary, derogatory reimbursement (prise en charge dérogatoire) based on a HAS-approved protocol;
- A requirement for prospective data collection to demonstrate utility in the French healthcare system;
- The possibility of transitioning to full reimbursement under NABM once sufficient evidence is available.
The test, developed by French medtech firm Vitadx, uses AI to assist in the cytological analysis of voided urine samples, aiming to identify urothelial carcinoma cells. It targets NMIBC patients undergoing routine surveillance, currently managed by repeated cystoscopies, which are invasive, costly and often uncomfortable.
In its opinion n° 2025.0027, HAS highlighted:
- The innovative nature of the device;
- The validity and robustness of the submitted real-world evidence protocol;
- The potential clinical and operational benefits if diagnostic performance is confirmed;
- That the test is not yet eligible for NABM reimbursement, but qualifies for temporary public funding under RIHN 2.0, conditional on evidence generation.
HAS based its decision in part on the VISIOCYT1 trial, a multicenter prospective study conducted in France.
Key findings on the trial included:
- 391 patients, including 170 with confirmed urothelial carcinoma and 149 controls;
- Overall sensitivity: 80.9%, exceeding the 70% threshold set by HAS;
- Specificity: 61.8%, slightly below the expected ≥75%, but acceptable within the exploratory context;
- For high-grade tumors: sensitivity of 93.7%;
- For low-grade tumors: 66.7% sensitivity—a notable improvement over traditional cytology;
- In a separate validation cohort, the test showed:
- 85% sensitivity overall (vs. 43% for standard cytology),
- 93% for high-grade tumors (vs. 61%),
- 77% for low-grade tumors (vs. 26%).
These results underscore significant improvements in diagnostic performance, particularly for the early detection of high-grade recurrences, where timely intervention is critical.
If fully validated, VisioCyt Bladder could:
- Reduce the frequency of follow-up cystoscopies, lowering procedural burden;
- Standardise cytological interpretation via AI augmentation;
- Improve the sensitivity and reproducibility of urine-based surveillance tests;
- Potentially enable remote or decentralised bladder cancer monitoring, if linked with telepathology systems.
The economic case hinges on:
- Avoidance of unnecessary cystoscopies (estimated cost per cystoscopy: €400–600);
- Reduction in missed high-grade recurrences;
- Enhanced workflow efficiency for pathologists;
- Early detection and treatment, reducing downstream cancer care costs.
The real-world data to be collected under RIHN 2.0 will be instrumental in establishing these cost offsets for a full NABM listing.
The HAS decision on VisioCyt Bladder illustrates several critical points for diagnostic developers targeting the French market:
- Innovation must be paired with a structured data collection plan. RIHN 2.0 requires both technical novelty and operational realism.
- AI and digital diagnostics are eligible for reimbursement support, but must demonstrate patient and system-level value.
- The route to NABM listing is increasingly reliant on in situ clinical data, not just CE-marked dossiers.
France’s decision to greenlight VisioCyt Bladder under RIHN 2.0 represents more than a one-off approval, it establishes a precedent for AI-enhanced diagnostics to enter reimbursement via conditional, evidence-linked access. As frameworks like PECAN, Article 51, and RIHN 2.0 converge on real-world utility, France is emerging as a leading test-bed for performance-based diagnostic funding in Europe.