Valencia, Spain – 11th January 2019. QUIBIM Precision® image analysis platform has received CE Mark certification as class IIa Medical Device, including the imaging biomarker analysis algorithms, the zero footprint DICOM viewer and the platform hosting these components and medical imaging data. With this milestone, the products are now ready for commercial deployment in European hospitals and diagnostic imaging centres.
The platform, which includes not only quantitative image analysis but also structured reporting capabilities, can be seamlessly integrated into the radiology workflow adding value to the specialists. In addition to the platform, this certification includes 15 algorithms grouped in the 5 main pillars of QUIBIM: Oncology (ADC Diffusion, IVIM Diffusion, Semiquantitative Perfusion, Pharmacokinetics Modeling, T1 mapping, T2 mapping) , Neurology (White matter lesions detection, Brain atrophy modules), Musculoskeletal (3D /2D Trabecular Bone Microarchitecture), Liver (Liver fat and Iron quantification), and Lung (Lung Emphysema and densities); Also included in the CE Mark certification is the DataMiner, which is designed to provide advanced visual analytics of large databases of patients for population health management and scientific exploitation, and the DICOM web viewer that enables the user to visualize the images of a sequence, draw ROIs or apply filters.
“We are so proud of getting the ISO 13485:2016 and the CE certification by BSI, one of the most prestigious notified bodies. This allows QUIBIM to commercialize QUIBIM Precision® as a Medical Device in the European market, which is a major milestone for our company.”, states Ángel Alberich Bayarri, CEO & Co-founder of QUIBIM. He adds, “Since its inception, QUIBIM has done extensive research and validation for its products together with European, American, Indian, and South American partners, ranging from top academic and research hospitals & diagnostic centres to the leading pharmaceutical companies and CRO’s, sharing the results in publications in both national and international congresses. Now with the CE Mark approval, QUIBIM is excited to commercialize its efforts in Europe and the regions of the world where the CE Mark is accepted.”
“QUIBIM is a company committed to improving diagnosis, which has a huge impact on patients quality of life. Therefore, quality is one of the aspects we pursue the most in our company, not only by certifying the quality of our product with the CE Mark but also at the organizational level. This is why we have established our Quality Management System based on and certified by the ISO 13485:2016, a standard related to the quality management system applicable to medical devices.” pointed Belén Fos Guarinos, Quality Assurance And Regulatory Affairs Manager at QUIBIM.
QUIBIM is a company from Valencia (Spain) which applies artificial intelligence and advanced computational models to radiological images to objectively measure changes produced by a lesion or by a pharmacological treatment, offering additional quantitative information to the qualitative approach of radiology. QUIBIM Precision® is the image repository and analysis platform provided by the company and is increasingly being used by customers across hospitals, clinical trials, research projects, biobanks and educational institutions across the world. The company is member of the European Institute of Biomedical Imaging Research (EIBIR) and of the Avicenna Alliance and receives funding from the H2020 program of the European Commission.
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