QED SureWave™ Elastography for Magnetic Resonance Systems – FDA Submission Announcement

Quality Electrodynamics, LLC (QED), a leading supplier of advanced technologies for Magnetic Resonance Imaging (MRI) systems, announces the 510k submission for the SureWave™ Elastography for Magnetic Resonance systems.  SureWave™ Elastography is a portable device to allow use between multiple MR scanners that features a novel patented gravitational-based (non-pneumatic) patient transducer technology. This innovative technology was  pioneered and prototyped by the School of Biomedical Engineering and Imaging Sciences, King’s College London, in collaboration with the LVTS INSERM 1148 Institute in Paris, and was funded by a European Union Horizon 2020 project entitled “Imaging the Force of Cancer” (FORCE, project number 668039, https://cordis.europa.eu/project/id/668039).

Magnetic Resonance Elastography (MRE) is a technique that applies mechanical waves to the body to support clinicians in non-invasive liver stiffness assessment. MRE is an established and widely accepted technique for evaluation of Chronic Liver Disease and is reimbursable under Category I CPT® code.

QED has developed this new device to enter the market with first system availability expected  end of 2024 upon FDA clearance. “This is a prime exemplar of the model of co-creation between the academic sector and industry. I am very proud we are working with industry partners to deliver benefits to patients at scale. This project demonstrates the uniqueness of these special partnerships.” says Professor Sebastien Ourselin FReng FMedSci, Head of the School of Biomedical Engineering & Imaging Sciences, King’s College London.

QED‘s SureWave™ technology is initially intended for use with Siemens Healthineers 1.5T and 3T MRI MAGNETOM scanners.

”Early detection of liver disease is vital for effective treatment and survivorship. In this context, we are proud to be the first to offer a new Magnetic Resonance Elastography device”, says Rebecca Ramb, Vice President Magnetic Resonance, Research & Clinical Translation, at Siemens Healthineers. “We collaborate with both renowned research partners and 3rd party companies to translate innovative methods into new solutions. These partnerships are key to bringing new methods into the clinic faster – for the benefit of patients.”

About QED
Quality Electrodynamics, LLC (QED) is a medical technology company founded in 2006 with a vision to revolutionize medical imaging to advance technical innovation in clinical diagnostics. QED applies innovation to support new MRI technologies and is a subsidiary of Canon Inc. since 2019.

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