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 […]
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 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 strengthens competitiveness with trademark protection within the EU
NanoEcho AB announces today that the name NanoEcho® and the company’s logo have been registered and granted trademark protection in all European Union member states. This dual registration is an important milestone to strengthen NanoEcho’s trademark portfolio and increase the company’s competitiveness ahead of commercial launches. The registration of the name NanoEcho® and the associated […]
NanoEcho AB and us4us Ltd. strengthen collaboration for future medical ultrasound technology
NanoEcho AB has signed a new letter of intent with us4us Ltd. regarding continued collaboration on the product development that was initiated with a letter of intent in July 2022. The collaboration is focused on the development of the next-generation ultrasound scanner module. According to the previous agreement, NanoEcho AB entered an active collaboration with […]
NanoEcho’s basic patent approved in Canada
The basic patent for NanoEcho’s method, previously granted in Japan, Europe, and South Korea, has now been approved also in Canada. The basic patent protects the performance of a hand-held probe with the unique combination of placing an ultrasound transducer together with one or more magnets on the same device. The same patent is under […]
Start of an investigator-led clinical development study at Skåne University Hospital
An investigator-led clinical development study has started at Skåne University Hospital in Malmö. In this context, the first examination of resected rectal cancer tissue has been performed with the NanoEcho diagnostic system. NanoEcho is developing a system that intends to improve the diagnosis of rectal cancer spread to nearby lymph nodes, an important marker of […]
Board member resigns at his own request due to medical reasons
At his own request, BG (Bengt-Göran) Svensson has chosen to leave NanoEcho’s board for medical reasons. At the same time, he announces that he is leaving all of his board assignments. BG Svensson has been an elected board member on NanoEcho’s board since 2020. “This was sad news, I have appreciated working together with BG […]
NanoEcho announces collaboration partner for the nanoparticle
NanoEcho and SPL medical have signed a Letter of Intent and initiated a cooperation on regulatory partnership and supply for the iron-oxide based nanoparticle. The aim of the collaboration is to achieve market approval for the NanoEcho indication, diagnostics of rectal cancer lymph node metastases. NanoEcho and SPL medical have signed a Letter of Intent […]
