The Board of Resonance Health is pleased to announce that the company has made an FDA 510(K) submission for HepaFat™ Scan.
HepaFat™ Scan is a software technology for the non-invasive quantitative measurement of fat in the liver utilising MRI medical images. A clinical study has been completed involving 60 patients with liver disease. The performance of HepaFat™ Scan was compared to the gold standard liver biopsy assessment of liver fat and the area under the receiver operating characteristic (AUROC) curve was used to assess the diagnostic performance of HepaFat™ Scan. The results were very good with an AUROC of 0.96 or higher in all categories of assessment and a high degree of sensitivity and specificity at all clinically relevant liver fat thresholds.
As the rate of obesity and the associated health care costs continue to increase, HepaFat™ Scan will provide an important tool to assist medical practitioners in the clinical diagnosis of fatty liver and in decisions on patient management. HepaFat™ Scan also provides a non-invasive alternative to a liver biopsy in clinical trials for therapies to address fatty liver disease, where repeat measurements are required throughout the clinical studies. Resonance Health hopes to receive a response from the FDA in the 4th quarter of 2012.
HepaFat™ Scan provides a non-invasive solution to the growing market demands in the area of fatty liver disease. This FDA 510(k) submission represents an exciting transition for the company from research and development to the commercialisation of HepaFat™ Scan.
Resonance Health is also nearing completion of a study aimed at developing an MRI-based test for assessing liver fibrosis. The Company is currently awaiting the final results from an external laboratory in order to complete the assessment of its product under development. An update will be provided as soon as the results of this study are known.
HepaFat™ Scan is a software technology for the non-invasive quantitative measurement of fat in the liver utilising MRI medical images. A clinical study has been completed involving 60 patients with liver disease. The performance of HepaFat™ Scan was compared to the gold standard liver biopsy assessment of liver fat and the area under the receiver operating characteristic (AUROC) curve was used to assess the diagnostic performance of HepaFat™ Scan. The results were very good with an AUROC of 0.96 or higher in all categories of assessment and a high degree of sensitivity and specificity at all clinically relevant liver fat thresholds.
As the rate of obesity and the associated health care costs continue to increase, HepaFat™ Scan will provide an important tool to assist medical practitioners in the clinical diagnosis of fatty liver and in decisions on patient management. HepaFat™ Scan also provides a non-invasive alternative to a liver biopsy in clinical trials for therapies to address fatty liver disease, where repeat measurements are required throughout the clinical studies. Resonance Health hopes to receive a response from the FDA in the 4th quarter of 2012.
HepaFat™ Scan provides a non-invasive solution to the growing market demands in the area of fatty liver disease. This FDA 510(k) submission represents an exciting transition for the company from research and development to the commercialisation of HepaFat™ Scan.
Resonance Health is also nearing completion of a study aimed at developing an MRI-based test for assessing liver fibrosis. The Company is currently awaiting the final results from an external laboratory in order to complete the assessment of its product under development. An update will be provided as soon as the results of this study are known.
Filed in: Health, Science & Technology
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