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FDA Approves Swedish Company's Technology for Getting More out of MRI Scans

January 31, 2018

The U.S. Food and Drug Administration has approved technology that the Swedish company SyntheticMR developed to give doctors more information from magnetic resonance imaging scans.

This means the company can begin selling its SyMRI NEURO packages to American medical facilities.

Traditional MRIs offer only one level of contrast when depicting tissue. SyMRI NEURO is the first to offer several levels, giving doctors more information about tissue properties.

This feature can help doctors who are studying multiple sclerosis patients’ brain scans get a better handle on damage to the myelin sheath that protects nerve cells. Deterioration of the sheath is a hallmark of MS.

The additional information should help doctors make better decisions on the diagnosis and treatment of MS patients, SyntheticMR said.

“FDA’s message is a milestone in the history of SyntheticMR,” Stefan Tell, the company’s CEO, said in a press release. “The clearance [approval] means we can now establish our entire product package on the U.S. market and offer clinicians objective decision support for a faster and more reliable diagnosis of their patients.

“A number of studies published this past year show the clinical benefits of SyMRI NEURO,” Tell said. “We are convinced that this is the beginning of a paradigm shift within MRI.”

SyntheticMR developed SyMRI NEURO in collaboration with Juntendo University Hospitalresearchers in Japan. The partners announced the technology’s development in 2015.

MRI is the preferred imaging tool for diagnosing and tracking MS. 

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