MEDICAL-DEVICE DEVELOPMENT
Progress must be visible, testable and evidence led
AquaBIT is an early-stage investigational platform. This page separates what exists today from what remains to be designed, tested and clinically validated.
Current position
The programme is progressing from computational feasibility towards an integrated research prototype. No AquaBIT system is currently approved for clinical diagnosis, treatment selection or patient management.
Performance claims will follow predefined technical and clinical evidence. Concept images and simulations are not presented as patient results.
Proposed first use
The initial programme is focused on research use in oncology: assessing whether serial conductivity measurements can be acquired reproducibly and correlated with accepted reference imaging, pathology and treatment response.
The final intended use and regulatory classification will be refined with specialist regulatory advice and engagement with the relevant authorities.
Five evidence gates
01. Computational
Human-body models, tumour-contrast assumptions, sensitivity maps and reconstruction-error analysis.
02. Phantom
Tissue-equivalent materials, controlled targets, repeatability, calibration and artefact testing.
03. Integrated prototype
Water chamber, electrode array, electronics, reconstruction workstation and safety controls.
04. Clinical feasibility
Ethics-approved assessment of safety, workflow, signal quality and reproducibility in people.
05. Clinical validation
Prospective multicentre comparison with reference standards and predefined clinical endpoints.
Safety and quality framework
Risk management
Hazards related to electrical energy, water, temperature, transfer, infection prevention, motion and emergency access will be identified, controlled and verified.
Design controls
User needs, system requirements, verification tests and design changes will be traceable through a controlled development record.
Standards strategy
Development is intended to align with applicable principles from ISO 13485, ISO 14971, IEC 60601 and clinical-research governance. Alignment does not imply certification.
Provisional regulatory direction
AquaBIT expects that any diagnostic or treatment-monitoring claim would require formal medical-device conformity assessment supported by analytical and clinical evidence. The UKCA, CE and United States pathways will depend on the final intended use, risk classification and claims. No regulatory submission or approval is currently claimed.
Last updated: August 2026. This page will be revised as the device definition and regulatory strategy mature.
Review the scientific pathway
See how each development stage is being translated into a focused oncology research programme.
AquaBIT Medical 