Development of a multichannel device for advanced resection of rectal tumors using flexible endoscopy and transanal endoscopic surgery UNI-VEC®
In collaboration with the Galician Health Service (SERGAS) and VECMEDICAL SPAIN S.L., the Instituto de Biomecánica (IBV) has developed an innovative multichannel device for flexible or rigid intrarectal endoscopy and rigid instrument-assisted removal of rectal lesions that cannot be treated using conventional flexible endoscopy techniques. The starting point was a conceptual idea defined by the clinical group, led by Dr. José Noguera, and all the stages of the development were carried out jointly, beginning with the conceptual design and including risk assessment, in vitro functionality tests, redesign, animal experimentation, design for manufacturing and the generation of the necessary documentation for CE marking and to begin clinical trials in humans.
Implications of the new MDR (EU 2017/745) for Class I medical devices
The period of transition for Class I medical devices to the new regulatory framework established by EU Regulation 2017/745 on medical devices, also known as MDR, will come to an end on 25 May 2021. As of this date, if they wish to continue marketing these products, all manufacturers and their respective products must adapt to the MDR.
This article will address the main changes introduced by the new regulatory framework and will provide the keys to a successful transition for class I medical device manufacturers.
Development of technologies for the Post-Market Clinical Follow-upof medical devices and evaluation of key performance indicators for hospital based on biomechanical functional assessment
The Instituto de Biomecánica (IBV) is setting up an innovative service for the biomechanical functional assessment and monitoring of daily activity that will make it possible to know the progress of patients with knee prostheses. This service will provide the manufacturers of medical devices with objective and relevant clinical information on the functioning of their products, which will strengthen their post-market surveillance systems. In addition, this service will benefit hospitals by allowing them to objectively measure the effectiveness of their procedures and rehabilitation treatments, thus helping them improve the resource management.
Development of a new device for the early diagnosis of Alzheimer's disease
Alzheimer's disease affects 14 million people in the world. To facilitate the effectiveness of new treatments, early detection of the disease is vital. The Valencian company Oncovision, with the collaboration of the I3M and the Institute of Biomechanics (IBV), has developed a new diagnostic imaging equipment based on PET technology that will make it possible to detect the disease in very early stages and with a high degree of accuracy.
BUSCAR / FIND
SOCIAL MEDIA
