NanoEcho submits application to the authority to start a clinical study
NanoEcho AB (publ), which develops a new diagnostic method to investigate the spread of rectal cancer to nearby lymph nodes, has today submitted an application to the Swedish Medicines Agency to evaluate the company’s medical diagnostic device in a clinical study. In the planned study, NanoEcho’s method will be used and evaluated on patients with […]
NanoEcho’s quality management system, certified according to ISO 13485
After an extensive review process, NanoEcho’s quality management system has today become ISO 13485 certified. This means that NanoEcho operates in accordance with the legal requirements for medtech companies, necessary for launching medical devices in the EU. This certification is in practice a legal requirement for the company to be allowed to launch medical devices […]
The development of the NanoEcho imaging device completed and ready for clinical studies
The development of NanoEcho’s commercial imaging device is now completed and ready to be used on patients, in clinical studies. The formal verification has today been successfully finalised without any remarks, which is the last step in the product development. This means that the device meets the customers’ and the authorities’ requirements for medical technology […]
Health economic model for introduction of NanoEcho’s diagnostic method: basis for care decisions and pricing strategy
NanoEcho has, in collaboration with health economic experts, developed a model for health economic analysis of the introduction of NanoEcho’s method in healthcare, with the aim of investigating the potential cost-effectiveness. The health economic model shows that the introduction of NanoEcho’s diagnostic method has the potential to generate health economic gains. This analysis will form […]
NanoEcho has entered into an agreement securing the supply of nanoparticles
Today, NanoEcho has entered into a comprehensive agreement ensuring the company’s access to iron oxide-based nanoparticles, Ferrotran® (ferumoxtran), both in the short and long term. The agreement with SPL Medical represents the company’s most significant deal to date, as the choice of nanoparticles is crucial for the optimal functioning of the company’s diagnostic method. The […]
NanoEcho strengthens its position through an agreement with Clinical Trial Consultants for the upcoming clinical phase
NanoEcho announces today that the company has entered an agreement with Clinical Trial Consultants (CTC), who will contribute with expertise, guidance, and preparatory activities for the upcoming clinical registration study. CTC is a Clinical Research Organization (CRO) and thereby specialised in planning, executing, and reporting clinical studies. The agreement means that CTC will provide expertise […]
NanoEcho submits a patent application for an advanced software algorithm for magnetomotive ultrasound
NanoEcho has officially filed a patent application with the Swedish Patent and Registration Office (PRV) for an advanced algorithm designed to enable the use of magnetomotive ultrasound in clinical examinations. The new patent aims to establish strong protection for a software algorithm that continuously calculates, filters, and visualizes clinical examination results in real-time during the […]
NanoEcho enters the formal verification phase
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 […]
NanoEcho and Peritus Clinic establish collaboration for the upcoming clinical registration study
NanoEcho AB (publ.) has today signed a letter of intent with Peritus Clinic AB in Lund, which includes collaboration in clinical image interpretation related to rectal cancer diagnostics. The initial focus will be on NanoEcho’s upcoming clinical registration study. The parties have reached an agreement to collaborate in the planning and execution of NanoEcho’s upcoming […]
NanoEcho expands its international network by meeting leading researchers and physicians in Glasgow
NanoEcho has participated in a meeting with international researchers in magnetomotive ultrasound as well as leading colorectal cancer physicians. At the meeting, NanoEcho’s imaging system was presented and discussed and its potential to improve health care for rectal cancer patients. This week, NanoEcho participated in a meeting in Glasgow together with internationally prominent researchers in […]
