LiverMultiScan receives regulatory clearance for clinical use in Australia
- August 14, 2018
We are delighted to announce today that our flagship product, LiverMultiScan™, has received clearance as a Medical Device from the Therapeutic Goods Administration. This clearance will allow clinicians in Australia to use LiverMultiScan as part of the diagnostic pathway for patients.
In Australia, imaging is a commonly used diagnostic tool for NAFLD, in particular, ultrasound. However, ultrasound has limited sensitivity for the disease when liver fat is below 30% or in the presence of obesity1.
Stephen Coyle, Founder at Medicoyle Resources and previous Chief Radiographer at Healthcare Imaging Services, stated that “Perspectum’s LiverMultiScan software has the potential to become the new gold standard in liver disease diagnosis. Integrating with MRI protocols, the process reduces the need for liver biopsies, sedation and short stay hospitalisation for patients. With increasing fatty liver disease in paediatric and adult patients in Australia, radiology departments will be able to support specialists and referring clinicians. With LiverMultiScan, departments will be able to maximise their MRI time on funded and unfunded magnets, increasing patient referrals."
NAFLD in Australia affects an estimated 5.5 million people, including 40% of all adults age 50 and above2. In 2015 NAFLD/NASH was the third most common indication for listing for liver transplantation in Australia and New Zealand3. Professor Sir Mike Brady, who received his doctorate at the Australian National University and is now Chairman of Perspectum Diagnostics, commented that “early diagnosis is vital for ensuring patients are given help and advice to prevent the progression of liver disease and I hope that the clearance of LiverMultiScan in Australia can aid in early diagnosis to minimise the extrahepatic complications."
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- Mahady, et al. 2018, Burden of non-alcoholic fatty liver disease in Australia, Journal of Gastroenterology and Hepatology 2018, (Suppl.1) 1-11
- Deloitte Access Economics: The Economic Cost and Health Burden of Liver Disease in Australia (Jan 2013)
- Bertot LC, Jeffrey GP, Wallace M et al, Nonalcoholic fatty liver disease-related cirrhosis is commonly unrecognised and associated with hepatocellular carcinoma. Hepatol. Commun. 2017;1: 53-60
Stephen Coyle is a distributor of LiverMultiScan in Australia.