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ProductsVisioCyt® Bladder

Vendor source

Reviewed 21 Jul 2026

Completeness Strong (75%)

VisioCyt® Bladder

VitaDX international

VisioCyt® Bladder is an AI-powered, solution designed to diagnose urothelial bladder carcinoma. By analyzing digital urine cytology, the device detects the presence of tumor cells based on their morphological atypia to predict the presence or absence of bladder cancer, and when applicable, an assessment of the tumour grade (high or low). VisioCyt® Bladder is intended to assist its prescribers in the diagnosis of patients exhibiting symptoms suggestive of bladder cancer or for individuals under surveillance for urothelial carcinoma.

Supported by 3 papers

Key features

Atypia scoring

Bladder cancer detection

Follow-up analysis

High grade/Low grade differentiation

Primary diagnosis

General Information

Product name

VisioCyt® Bladder

Modality

Cytopathology

Main task

Detection, Grading

Subspeciality

Urologic cytopathology

Organ/Specimen source

Not specified

Disease targeted

Bladder cancer

Specimen type

Voided urine

Staining

Pap

Stain subtype

Not specified

Regulatory Information

CE-IVD Certification

Pathway:

In Vitro Diagnostic Regulation (IVDR)

Class:

Class C

Not verified by Health AI Register

Scanner Brands Certified for Use (CE-IVD)

Hamamatsu

Scanner Models Certified for Use (CE-IVD)

Hamamatsu S20, S60, S360 and S540 MD

Other certifications

Not specified

Evidence & Research

Technical Specifications

Patient population age

Adult

Input

Whole slide image of voided urine cytology slides and some patient data such as: age, sex and smoking status.

Input format

Hamamatsu (NDPI, NDPIS)

Output

Positive, nagative or Non conclusive with overall atypia score.

Output format

PDF report, TAR

Integration

Integration with LIS (Laboratory Imaging System), Stand-alone third party application

Deployment

Locally on dedicated hardware

Trigger for analysis

Automatically, right after the image acquisition

Processing time

1 - 10 minutes

Population

Compatible population: Patients with symptoms of bladder cancer as part of a primary diagnosis and patients in follow-up; Non compatible population: Under 18 years of age, With an untreated urine tract infection non compatible with a vesical endoscopy, Having undergone bladder reconstruction (Hautmann or Bricker type), Who perform intermittent self-catheterization, With a urine catheter (JJ type), With a bladder cancer other than a urothelial carcinoma, With a history of or an ongoing associated upper tract carcinoma, With a lithiasis pathology, Having undergone a renal transplantation (BK virus infection), Having had radiotherapy in the pelvic region (as part of prostate cancer therapy).

Viewer systems

Not specified

Market Presence

On market since

June 2022

AI Platforms

Resellers

Not specified

Countries present

France

Paying clinical customers

Medipath

Research/test users

Not specified

Pricing Information

Pricing model

Pay-per-use

Based on

Number of analyses

Source: Vendor | First published: Jul 30, 2025 | Last updated: Jul 21, 2026