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QUIBIM CE MARK - ISO13485 2016

QUIBIM algorithms, viewer and platform get
CE Mark certification

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.

QUIBIM areas

“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.

About 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.

More info at:

contact@quibim.com
+34 961 243 225
www.quibim.com

Download: QUIBIM algorithms, viewer and platform get CE Mark certification

QUIBIM Imaging Biomarkers made transparent

QUIBIM, AI imaging disruption to showcase the value of Precision

We are in the era of Precision Medicine, and so is Radiology. Nowadays, main imaging modalities like X-ray, computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET) and hybrid machines, among others, have become measurement instruments. Images are not only pictures anymore, but thanks to the application of computational analysis and artificial intelligence, they are data, as you can learn in this excellent manuscript in Radiology.

Nowadays, when radiologists perform measurements of different organs, tissues and lesion properties using a workstation, they are used to get a number (i.e. lesion volume or perfusion). If they take the same images and they get to analyze them in a workstation from another vendor (not straightforward), it is pretty sure that they will obtain different results. This issue has introduced a sense of lack of standardization and homogenization in the quantitative medical imaging field.

I like to say that value is to trust in the product, and we have decided to be the first company in the world to open the validation process and tests results of our imaging biomarkers. Every time we buy a measurement device for daily life purposes (i.e. thermometer) we know the degree of uncertainty, why wouldn’t we do the same in AI algorithms and quantitative imaging?

We are proud to make this announcement at ECR 2018: Now it is possible to see the precision, accuracy and clinical evaluation results of our imaging biomarkers. We provide the precision (through Coefficient of Variation, CoV) and accuracy (through relative error, e) values through the publication of QUIBIM Technical Datasheets that you can find in the resources section of our webpage.

With this strategy QUIBIM is going a step further by being the first multi-vendor, web-based and real precision Medicine company of the medical imaging & AI market.

Concerned by the accuracy of your measurements? Let’s work together.

Metrology for imaging biomarkers

Will metrology labs take charge of Imaging Biomarkers certification?

As the reader might know, Imaging Biomarkers are parameters obtained objectively from medical images, which represent and quantify a tissue property (structural, functional or biological) extracted after applying computational models to images of specific medical imaging modalities like computed tomography (CT), magnetic resonance imaging (MR), conventional radiography (CR) and so on.

One of the main challenges for Imaging Biomarkers integration in clinics and in clinical trials is the need for standardized image acquisition protocols  and  pipelines for the analysis of imaging biomarkers, including the processing, analysis and reporting of the results.

As specified in this publication from QIBA (Quantitative Imaging Biomarkers Alliance) team: “Most Biomarkers require a computation algorithm, which may be simple or highly complex. While there is a rich history of the development of biomarker techniques, there has been comparatively little attention paid to the evaluation and comparison of the algorithms used to produce the biomarker results. Estimation errors in algorithm output can arise from several sources during both image formation and the algorithmic estimation of the biomarker. These errors combine (additively or non-additively) with the inherent underlying biological variation of the biomarker. Studies are thus needed to evaluate the imaging biomarker assay with respect to bias, and precision. A recurring issue is the lack of reported estimation errors associated with the output of the biomarker. Another challenge is the inappropriate choice of biomarker metrics and/or parametric statistics. For example, tumor volume doubling time is sometimes used in studies as a biomarker. However, it may not be appropriate to use the mean as the parametric statistic for an inverted, non-normal, measurement space. Since a zero growth rate corresponds to a doubling time of infinity, it is easy to see that parametric statistics based on tumor volume doubling time (e.g. mean doubling time) may be skewed and/or not properly representative of the population. In addition, there may be discordance between what might be a superior metric statistically and what is clinically acceptable or considered clinically relevant. For example, a more precise measuring method will typically better predict the medical condition, but only until the measurement precision exceeds normal biological variation; further improvement in precision will offer no significant improvement in efficacy. Finally, when potentially improved algorithms are developed, data from previous studies are often not in a form that allows new algorithms to be tested against the original data.

A metrology-by-design strategy for imaging biomarkers design and implementation has still not been conceived, however, there is a clear need to fill this gap, since medical images are suffering a paradigm shift from being qualitatively interpreted by radiologists to become a powerful measurement instrument, that can provide a non-negligible and highly relevant information in many pathological processes.

Following the experience of our group and QUIBIM, with a model of success for the integration of quantitative image analysis in clinics, we published in 2012 our methodology for the integration of imaging biomarkers in clinics that was later supported by the European Society of Radiology in 2013, through the publication “ESR position on the stepwise development of imaging biomarkers” in Insights into Imaging. This paper was the former work of the ESR supporting the creation of the European Imaging Biomarkers Alliance (EIBALL) in 2015.

Now, several actions should be undertaken to allow for the implementation of biomarkers in clinical use and the evaluation of therapy response:

  • To determine the most significant sources of uncertainty for imaging biomarkers.
  • To establish a standard methodology for definition of the method and the protocol for image acquisition (Signal-to-noise ratio, contrast-to-noise ratio) for traceable measurements.
  • To harmonise calibration routes and methods for imaging biomarkers in European metrology institutes. This objective includes knowledge exchange and transfer and comparison measurements.
  • To provide metrology input and pre-normative research to the evolution of International (ISO, EN) standards concerning imaging biomarkers.
  • To engage with image device manufacturers to facilitate the take up of the technology and measurement systems developed, to support the development of new, innovative biomarkers, thereby enhancing the competitiveness of EU industry.

While researchers are dealing with these issues, there are specific entities that have been always in charge of supervision, validation and certification of measures: the National Metrology Institutes. The umbrella covering all National Metrology Institutes in Europe is EURAMET. Therefore, we should start to think in incorporating this metrology-by-design strategy in the process of creation, implementation and validation of imaging biomarkers. In QUIBIM we have already started this strategy, following QIBA recommendations and implementing new algorithms in a modular basis, identifying the sources of uncertainty in all the measurements that we perform with imaging biomarkers.

by Angel Alberich-Bayarri (@aalberich).

CEO & Founder of QUIBIM