Resonance Health Ltd is pleased to announce that it has received 510(k) clearance from the U.S. Food and
Drug Administration (FDA) to market its cardiac iron test, called MRI-Q, in the United States. The test measures
an MRI parameter known as cardiac T2* which is highly sensitive to cardiac iron loading.
This follows the Health Canada approval received by the Company in July 2011 and TGA and CE Mark
approvals obtained in 2010.
This announcement represents an important step forward for the Company. Resonance Health has received
considerable demand for the cardiac T2* iron test from its existing US customers and anticipates strong uptake
in this market.
Cardiac iron overload is the major cause of death in β-thalassaemia major patients. A service to provide an
accurate non-invasive test for both liver and cardiac iron measurements will be made available to clinicians,
offering significant improvement to patient management and outcomes.
The Company will also explore opportunities to provide this new test to clinical trials concerned with the
assessment of iron overload therapies. For further information on measurement of cardiac T2*, click here |
Login
