Regulatory Status

Curenetics is committed to developing safe, high-quality, and transparent technologies that advance scientific understanding in oncology. Our current software platform and analytical tools are made available for research use only and are not classified as medical devices at this time.

Curenetics is actively preparing for future regulatory submissions in major global markets, including:

• United States – U.S. Food and Drug Administration (FDA)

• European Union – EU Medical Device Regulation (MDR)

• United Kingdom – MHRA regulatory framework

To support these future pathways, Curenetics is building the internal systems and evidence base required for regulatory evaluation, including:

• Implementation of quality management processes

• Establishment of software lifecycle and documentation controls

• Development of analytical and clinical validation frameworks

• Robust data governance and cybersecurity practices

• Risk-management and post-market surveillance planning

Our long-term objective is to ensure that Curenetics’ technologies meet the stringent requirements expected by regulatory authorities while maintaining scientific rigour and patient safety.

Until formal regulatory approval is obtained, all Curenetics tools and outputs remain research-only and must not be used for diagnosis, treatment decisions, clinical management, or any purpose requiring regulatory clearance.

For questions regarding regulatory activities or compliance planning, please contact us.