FAQ for Urologists

PCa stands for Prostate Cancer. PCaVision is an AI-powered software application that facilitates urologists to diagnose prostate cancer, using 3D ultrasound imaging, removing the need for MRI scans and radiologist involvement in the diagnostic process. PCaVision enables single visit prostate cancer diagnostics directly in the urology clinic – fast (within 30 minutes), accessible, and at reduced cost, providing a solution to the global capacity problem in prostate cancer diagnostics.

PCaVision visualizes suspicious lesions as a 3D color map overlaid on a B-mode ultrasound image. Examples of the PCaVision output are shown below:

Patient A: Suspicious lesions detected

Patient B : No suspicious lesions detected

The PCaVision output, when considered alongside other diagnostic information – including PSA density, digital rectal examination findings, family history, and patient age – enables the urologist to plan targeted prostate biopsies as part of the standard PCa diagnostic pathway.

PCaVision can be used to facilitate prostate cancer diagnosis without the need of MRI in the clinical pathway. PCaVision will give you information about the presence and location of highly suspected lesions, targetable for prostate biopsies.

No. PCaVision provides the urologist with the necessary information to determine whether and where to take targeted biopsies.

Yes. PCaVision received CE marking in July 2025.

PCaVision provides several advantages for both urologists and patients:

  • Eliminates delays associated with radiology scheduling and reporting
  • Streamlines the diagnostic pathway by reducing three MRI-based pathway consultations to a single visit
  • Rapid availability of results: 12 minutes of ultrasound acquisition and 4 minutes of processing
  • Avoids external MRI-related costs
  • Retains diagnostic control and revenue within the urology department

The PCaVision workflow consists of two phases:

  1. Image acquisition – recording a TRUS ultrasound sequence, performed by any TRUS-trained sonographer or by the urologist.
  2. Interpretation – after automated analysis, the PCaVision output is reviewed and interpreted by the urologist to plan and perform targeted biopsies

Yes. Proficiency in image acquisition is typically achieved within 3 to 4 patient procedures. Interpretation proficiency can be attained with 2 to 3 hours of dedicated training.

During the acquisition phase, the ultrasound system captures sequences in multiple modalities: B-mode, Doppler, Shear Wave Elastography, and Contrast Enhancement. These sequences are automated via macros on the ultrasound scanner. The images are then automatically transferred to the PCaVision workstation, where advanced AI-based analysis is initiated. Once complete, the results can be reviewed via the PCaVision DICOM viewer.

No. PCaVision requires advanced 3D ultrasound capabilities that are currently available only on the GE LOGIQ E10 ultrasound platform. Accordingly, PCaVision is certified exclusively for use with this scanner.

Yes. PCaVision requires the acquisition of a Contrast-Enhanced Ultrasound (CEUS) sequence. This involves administering a dose of SonoVue[1] to the patient. The contrast agent, consisting of lipid-shell microbubbles, enhances the visualization of (micro)vascularity in the prostate.

[1] SonoVue (Bracco) obtained European Medicines Agency (EMA) marketing authorization in 2001. Its approved indications include enhancement of vascular imaging in liver and breast lesions during Doppler sonography in adults. The use of SonoVue within the PCaVision diagnostic pathway is currently off-label. For detailed product information, please refer to the manufacturer’s official documentation.

No. The overall cost of a PCaVision examination is lower than that of a radiologist/MRI-based examination, generating cost savings and favorable margins. Detailed cost analyses tailored to specific clinical settings are available. Furthermore, PCaVision has partnered with a leasing provider to eliminate the need for upfront capital investment.

PCaVision will be available for clinical use from December 2025 in Europe, with country-specific availability depending on compliance with local regulatory requirements. Reach out to PCaVision for availability in your country.