Q4 2017 brings both FDA 510 and renewed CE label

December 15th 2017

Nano4Imaging received (renewed) CE label for its existing and new guidewire (EmeryGlide TM). Within the last quarter we have now obtained both FDA 510 K and CE labels and are eager to move forwards with our clinical and business partners to move more and more cathlab procedures to the MRI suite. We would like to thank our contract manufacturer CMI (Dresden) for their endurance and persistence to get the certifications timely. Please come and see us at the CMR2018 in Barcelona (Jan 31st -Feb 3rd 2018) or at AEPC in Athens (May 10-12th 2018). In the meantime we will also set-up our sales and clinical applications in the USA. It will be an exciting clinical year for Nano4Imaging!!

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SPECTRE among highest ranking applications in Eurostars!

Our Eurostars application SPECTRE received a very high score in the evaluation process and we look forward to start-up the consortium with Radboud Medical Centre (Nijmegen, NL), Soteria Medical BV (Arnhem, NL), Fraunhofer MEVIS (Bremen, DE) over the next few months. The target is to further develop catheters that allow PTA applications under MRI to further support our vision and product development towards real MRI-guided interventions, such as fistula repair and iliac stenosis repair. A big applause for TTopstart who has helped us to write the grant. Radboud UMC will be able to further extend its MITEC facility and will help to further augment MRI guided procedures.

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TED talk with Nano4Imaging technology explained

On February 13th 2017, Paul Borm (Founder and CSO of Nano4Imaging) gave a TED talk in which he talks about innovation as results of energy explosions. During his talk he brings nanotechnology forward as a discipline that needs cross-border collaboration to understand the use and applications of new (nano)materials. To explain this he shows a movie a MRI guided stenting in a pig renal artery during his talk. He also stresses the importance of open innovation.

Still-TEDtalk-Borm-13022017

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CMR and AEPC meetings in Florence and Rome

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Both at EuroCMR in Florence (May 13th) and on June 2nd in Rome (Italy) at the European pediatric cardiology society (AEPC) there were memorial symposia to remember the efforts and inspiration of dr Sohrab Fratz in the field of congenital heart diseases. Dr Fratz shared and co-developed Nano4Imaging’s vision that cathlab procedures can be transferred to the MRI suite, in an effort to improve quality of the procedure at the same reducing radiation for both patient and doctor. The first data on measuring invasive blood pressure using of the MRWire in patients were presented at the  AEPC symposium by Kristina Belker from the German Heart Institute Munich.

At the same symposium dr Aphrodite Tzifa (First in man congenital heart disease MRI guided intervention, Circulation, 2010) praised the efforts of Nano4Imaging to bring a guidewire to the market.

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MRWire receives Health Canada license

On december 21st 2015 our MR conditional guide wire received a license (number 96312) from Health Canada. We will only start our sales in Canada, after completion of the post-market clinical follow-up (PMCF) which is ongoing in Europe. This is a great news at the end of an important year for Nano4Imaging. Thanks all for your confidence and let’s move on in 2016 the widespread clinical use of MRI based procedures.

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