Resonance technology gets regulatory support
Monday, 13 February, 2006
Australian and European authorities have eased the regulatory pathway for Resonance Health (ASX:RHT), by endorsing quality assurance systems for the Perth-based firm's FerriScan technology.
"These new certifications will replace the existing requirements to obtain TGA and CE mark clearance for each version of the FerriScan analysis software," said Resonance's director of marketing and sales, Glenn Smith. "This allows us to reallocate our cash resources to further product development and income generating activities.
"The benefits include both a reduction in resources, as a result of not having to apply for multiple assessments and also a greater flexibility in software and process development."
FerriScan has previously been listed on the Australian Register of Therapeutic Goods by the TGA, has been granted the European CE mark and marketing clearance in the US by the FDA.
FerriScan is a non-invasive test which measures the iron content of the liver, and can be used to detect and treat iron overload disorders including thalassaemia and haemochromatosis using specifically configured MRI machines. Scan data is analysed at a centralised RHAS image processing centre using proprietary software.
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