Research and educational use only

What this means in practice

Vea reconstructs and displays anatomy from imaging data that has already been acquired, and lets that anatomy be explored, measured and used for spatial simulation. It is a visualization and research instrument. It is not a diagnostic system, and it is not part of any regulated clinical pathway.

Vea does not

• detect, identify, grade or exclude disease;
• produce a diagnostic report or any output intended for diagnosis;
• select, size or recommend an implant, device or prosthesis;
• plan, guide or evaluate a procedure or a treatment;
• predict outcome, risk or prognosis;
• replace established imaging review, established planning tools, or the judgement of a qualified clinician.

What virtual implant simulation actually is

The platform can place a representation of a device inside a patient-specific reconstruction so that fit, orientation and the distances around it can be looked at. That is a spatial and educational exercise. It is not device selection, it is not sizing, and it is not procedural planning. Any decision about a real device for a real patient must be made with regulated tools, the manufacturer's instructions for use, and clinical judgement.

What we do not claim

We do not claim that using Vea improves survival, reduces complications, shortens procedures, makes surgery safer or improves any clinical outcome. Published studies that examine the platform look at measurement agreement and at how readers perceive spatial relationships; those are the claims their authors make, in their settings, and we present them as such on the research page. Nothing published so far establishes an outcome benefit, and we will not imply one.

Responsibilities of the user institution

Where a hospital, university or research group uses Vea, the institution remains responsible for:

• ensuring that its use stays within research and educational purposes;
• the clinical care of its patients and every decision taken in that care;
• ethics approval and study governance for research use;
• the lawful handling of imaging data, including anonymization and data protection;
• compliance with local rules on software used in the clinical environment;
• the accuracy and adequacy of any teaching content it builds with the platform.

Data quality

A reconstruction can only be as good as the dataset behind it. Acquisition parameters, slice thickness, contrast timing, gating, motion and artefact all affect what appears in the three-dimensional view, and a plausible-looking reconstruction from an inadequate dataset is the failure mode worth worrying about. Everything seen in the model should remain traceable to the source images, and the source images remain the reference.

Training and this statement

The same boundaries apply in our workshops. Training teaches the use of visualization software; it is not clinical instruction, it certifies attendance rather than competence, and it does not displace institutional protocols. That is stated again in the terms of sale.

If regulatory status changes

Should the regulatory position of the platform change in any market, this page will say so explicitly, with the scope and date of that change. Until it does, the statement at the top of this page is the current and complete position. If you need a written confirmation of regulatory status for a procurement or ethics file, write to support@virtual-simulations.pro and we will provide one on company letterhead.