Canadian regulatory clearance for Resonance’s FerriScan
18-April-06 by Edited announcement
Nedlands-based Resonance Health Ltd has announced it has been granted Canadian regulatory clearance by Health Canada for FerriScan, its novel non-invasive diagnostic test for liver iron concentration.
The regulatory clearance allows Resonance to market the FerriScan test in Canada where an estimated 150,000 people are afflicted with iron overload disorders such as haemochromotosis and thalassaemia.
Health Canada clearance for FerriScan follows the achievement of U.S. Food and Drug Administration marketing clearance, the listing of FerriScan by the Australian Therapeutic Goods Administration, and achievement of European CE Mark.
“Health Canada marketing clearance is a significant milestone for Resonance. Canada is a sophisticated market where clinicians see FerriScan as a major advancement in the way they can measure and monitor iron levels in patients. As we are currently doing in other parts of the world, we will partner with leading hospitals, diagnostic imaging centres, clinicians and patient advocacy groups in Canada to offer the FerriScan test to the public. In doing so we believe the Canadian market will be a strategic segment in the overall achievement of the business goals for FerriScan” said Dr James Williams, Managing Director of Resonance Health Ltd.