NanoEcho has conducted a "Design Input Review" – a systematic review of collected requirements and development plans for the product development phase. The company now enters a detailed design development phase with the objective of developing a prototype prepared for commercialization.
The result of the conducted review is that all requirements; clinical, regulatory, technical and user requirements, have been defined and documented. The conclusion of the review is that plans are now established to manage risks, clinical evaluation, and product development. This ensures that the company has a well-defined plan to develop a commercial product. A key input has been the feedback received from the ongoing clinical development study on surgically removed rectal cancer tissue.
To have passed our "Design Input Review" is an important step in our journey to become a more market-oriented product development company. We have gradually reinforced the organization and we now have a team that knows what it takes to put medical devices on the market. My assessment is that we are well prepared to enter a more detailed development phase of our commercial system, says Linda Persson, CEO for NanoEcho.
We are working systematically according to our newly established quality management system adapted to the medical devices industry. The company is now entering a more detail-oriented product development phase with the aim to develop a prototype prepared for commercialization.
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Kristina Hallström, CMO & CCO
NanoEcho has developed a new technology for clearer diagnostics of, as the first phase, rectal cancer. The imaging technology is based on a new medical approach where nanotechnology is used in combination with modern ultrasound technology. The images that are generated are intended to facilitate differentiation between healthy and diseased tissue and at the same time determine the location of the cancer tissue more precisely. The aim is to provide more precise, simpler and less costly diagnosis of cancers and other diseases. With clearer diagnostics, the company wants to assist treating physicians with better guidance for more personalized treatment. Both the quality of life of the patients and their chance of survival can improve after treatment, with reduced treatment costs. www.nanoecho.se