Prostate AI solution receives CE mark under EU MDR

Quantib, an artificial intelligence solutions provider for precision diagnosis, has obtained class IIb CE marking under the new MDR laws for its Quantib Prostate solution. 

After having received FDA clearance for clinical use in the United States in October 2020, this AI solution is now available for the European market. 

Quantib Prostate, leveraging the power of deep learning algorithms, dramatically improves the MRI prostate reporting workflow accessible directly from the radiologist’s reading station. Moreover, the solution comes with a suite of tools to improve reporting quality and speed: including AI-based volumetry and PSA density calculation, precise registration and movement correction, one-click segmentation of lesion candidates, classification and standardised reporting to facilitate easy and comprehensive communication of results. 

Arthur Post Uiterweer, CEO of Quantib, said: “Many European hospitals were waiting for this moment and it is fantastic that we can now bring this solution that is so well received in the US to radiologists across Europe.”

New healthcare guidelines introduced in 2019 and 2020 make an MRI scan of the prostate a standard procedure for every patient that requires a prostate biopsy. Triple digit growth in MRI prostate scans is the result in the coming years, however, there are not enough expert radiologists to report all these extra scans.

Sapienza University Hospital in Rome is one of the first sites in Europe that purchased and received an installation of Quantib Prostate. 

Prof. Valeria Panebianco, radiologist at Sapienza University Hospital, said: “At Sapienza we are always eager to discover and experiment with new AI tools to further promote research in imaging.”