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Sydney Neuroimaging Analysis Centre announces TGA (Class 2) approval of our flagship medical imaging-AI product, iQ- solutions

05 July 2024

Sydney Neuroimaging Analysis Centre announces Therapeutic Goods Administration (Class 2) approval of our flagship medical imaging-AI product, iQ-solutionsTM.  Approval for marketing in Australia complements existing US FDA 510K clearance of iQ-solutionsTM, a state-of-the-art AI tool that delivers precision quantitation of brain structures directly to the radiologist’s usual workflow, facilitating personalised monitoring and management for people with chronic neurological diseases such as multiple sclerosis and cognitive decline/dementia.


“TGA approval of iQ-solutions represents an opportunity to enhance the care of patients with multiple sclerosis through improved detection of disease activity on MRI scans (A real-world clinical validation for AI-based MRI monitoring in multiple sclerosis), while reducing a growing burden on radiologists and clinicians, ” said Professor Michael Barnett, Chief Research Officer at SNAC


“The advent of new biologic therapies for Mild Cognitive Impairment and early Alzheimer Dementia also increases the impetus to precisely monitor structural brain changes in this patient population with clinically integrated tools such as iQ-solutions.  Soon, SNAC will add important functionality to accurately detect and quantitate ARIA, an inflammatory brain condition known to complicate these therapies in some patients”


About iQ-solutions

SNAC’s iQ (intelligent quantification) product series provides robust, quantitative analysis of brain structures from MRI images, delivering personalized monitoring and precision management for people with chronic neurological diseases. With iQ solutions, both radiologists and physicians can accurately assess changes in a patient’s brain structure in real time.  For example, changes in the volume and location of ‘lesions’ in multiple sclerosis and cerebrovascular disease; and regional brain volume changes in Alzheimer dementia and other neurodegenerative diseases can be rapidly assessed, guiding management strategy and providing a quantitative evaluation of treatment response.


About SNAC

Sydney Neuroimaging Analysis Centre is an Australian neuro-imaging biomarker SME with a proven track record of R&D translation to clinical trials, and the only regulatory-compliant central MRI reading centre servicing the pharmaceutical industry in the Southern hemisphere.  SNAC uses structural and advanced image analysis, and deep learning solutions to further the understanding of neurological disorders, and develop tailored imaging biomarkers for clinical trials of emerging therapeutics.  SNAC also produces AI-based SaaS and SaMD solutions for the quantitative monitoring of chronic neurological disease with MRI; and the identification of critical brain abnormalities on head CT.  SNAC also produces informatics solutions for the management, routing and databasing of medical scans in clinical and research workflows.


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