SyMRI 15 by SyntheticMR obtains CE-Marking
SyntheticMR announced today that version 15 of their next-generation imaging solution, SyMRI Neuro, has obtained CE-marking.
SyMRI 15 is a cutting-edge imaging solution set to transform the medical imaging landscape with a host of innovative applications integrated into SyMRI's post-processing suite. In addition to the previously communicated launch of SyMRI 3D (14), the reinforced solution now include images that are proven to have the same capability as conventional for diagnostic purpose and thereby offer even more value from same sequence.
SyMRI 15 has been clinically proven and validated in a large multi-center study across several high-profile institutes in the United States. The results of the clinical study showed that SyMRI 3D can replace conventional 3D images, enhancing both efficiency and throughput. This is in addition to its established capabilities in providing quantitative values and tissue segmentation. The findings reinforce its diagnostic accuracy, instilling confidence in SyMRI users to substitute conventional 3D images with SyMRI T1 and T2 images.
With the introduction of SyMRI 15, we are also unveiling tools for efficient patient monitoring, alongside providing contrast-weighted images and quantitative information. This technique empowers clinicians with deeper insights into patient health, enabling improved patient care by facilitating a more comprehensive understanding of pathological changes and treatment effects over time.
"We are thrilled to announce that Version 15 of our 3D SyMRI solution is now CE-marked,” says Ulrik Harrysson, CEO of SyntheticMR AB. “This next generation of SyMRI 3D delivers unparalleled resolution and accuracy in brain imaging, transforming the field of medical diagnostics."
SyntheticMR has an exclusive agreement with Philips Healthcare for the distribution of SyMRI 15. This agreement between Philips and SyntheticMR means that SyMRI 3D will be included in Philips’ global price book and enable Philips to offer the complete package to their customers.
The CE mark qualification for SyMRI 3D signifies a monumental stride for SyntheticMR, reaffirming its commitment to transforming medical imaging on a global level.
This disclosure contains information that SyntheticMR AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 26-06-2024 13:30 CET.
For additional information, please contact Ulrik Harrysson, CEO, SyntheticMR AB, +46 70 529 2987 ulrik.harrysson@syntheticmr.com.
SyntheticMR AB develops and markets innovative software solutions for Magnetic Resonance Imaging (MRI). SyntheticMR AB has developed SyMRI®, delivering multiple, adjustable contrast images and quantitative data from a single 5-minute scan. The SyMRI product is available in different packages. SyMRI NEURO delivers multiple contrast images, tissue segmentations and quantitative data on the brain. SyMRI MSK provides multiple contrast images and quantitative data for knee and spine anatomies. SyMRI NEURO is CE-marked, and FDA 510(k) cleared and SyMRI MSK is CE-marked. SyMRI 3D is 510(k)-pending and CE-marked. SyMRI is a registered trademark in Europe and the USA. SyntheticMR is listed on the Spotlight Stock Market Exchange in Stockholm, Sweden. For more information, visit www.syntheticmr.com.