Resonance Health Limited Receives FDA Approval for MRI-Q Cardiac Iron T2* Test
16 Agosto 2011 - 8:30AM
Business Wire
Resonance Health Ltd, a medical device company specializing in
imaging core laboratory services has received FDA clearance to
market its MRI-Q System. The test measures cardiac T2* which is a
highly sensitive surrogate marker for cardiac iron.
Resonance Health’s other product on market is FerriScan® R2-MRI
(www.ferriscan.com), which provides an accurate assessment of liver
iron concentration (LIC). The MRI-Q system provides an opportunity
to broaden the Company’s range of solutions to address the iron
overload market.
Iron overload can occur in patients who are dependent on blood
transfusions for the treatment of conditions such as thalassemia,
sickle cell disease and myelodysplastic syndrome. It can also be
caused by excessive dietary absorption of iron through hereditary
hemochromatosis, one of the most common genetic disorders in the
United States. Iron overload can result in organ damage and the
accumulation of cardiac iron is the leading cause of death in
patients with β-thalassemia major.
FerriScan R2-MRI and now the MRI-Q system are provided to the
market as a combined service for both the liver and cardiac T2*
iron assessment. To access FerriScan R2-MRI and MRI-Q, an MRI
center transmits image data electronically via a secure internet
portal to the Company’s quality-controlled, ISO9001 certified
central core lab where experts conduct the analysis. Resonance
Health can now provide clinicians with added value by including
both liver iron and cardiac T2* results in the data analysis.
“Customers can start using the service immediately,” said Liza
Dunne, Managing Director. “There are no additional software or
hardware purchases needed and the price of MRI-Q and FerriScan
R2-MRI is charged on a “per-scan” basis. FerriScan R2-MRI is
currently used by global pharmaceutical companies in multicenter
clinical trials for iron chelation therapy products and by several
hospitals in the United States. Cardiac iron assessments will be
delivered with the same standards of quality and consistency that
clinicians have come to expect from FerriScan R2-MRI.”
Resonance Health is also developing technology for the
quantitative MRI-based measurement of fatty liver and liver
fibrosis and welcomes collaborations in these fields.
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