Today, NanoEcho enters the formal verification phase of its imaging system, in which ultrasound is used in conjunction with nanoparticles to improve rectal cancer diagnostics. This means that the integration and interaction process has been completed, an internal evaluation of the system's performance has been made and documentation has been compiled. An independent review process has been carried out to ensure that the documentation complies with the regulatory requirements.
In 2022 NanoEcho developed a system intended to meet the requirements of the authorities and customers and in 2023 the focus has been on integrating the various parts of the imaging system. Software has been developed and implemented to control the system, process the data, and visualize the examination results. In parallel, a modern user-friendly interface has been developed. In addition to this, informal verification, and extensive internal testing, have been carried out. The results of the work have been documented, reviewed and approved and NanoEcho will now enter the formal verification phase.
In the formal verification phase, NanoEcho's imaging system will undergo controlled tests and evaluations, including tests performed by independent external test-institutes. In this way, it is ensured that the system formally meets all regulatory requirements and that it is therefore safe to use on patients.
After completion of formal verification, a regulatory-controlled clinical registration study is planned. This means that in parallel with the formal verification, the company is also preparing the production of units to be used in the planned study.
"I am extremely proud of the progress we have made. Through our goal-orientated work, combined with our extensive experience in MedTech, we are now advancing our position even further. We are confident with the results and will now have the system formally reviewed by external bodies." says Linda Persson, CEO of NanoEcho.
If you have any questions, please contact
Kristina Hallström, CMO & CCO