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Australian Clinic Moves Early On AI Regulation With TGA Submission Of ROSE Clinical Support System

By Julius Ewudo, Cyber Era NG ASEAN Region Representative Botaniqal Clinics Australia has formally submitted its AI-enabled Clinical Decision Support Software (CDSS), ROSE, to the Therapeutic Goods Administration (TGA) for registration as Software as a Medical Device (SaMD) (Submission Reference: ANON-EH3X-D4JK-5). The submission represents an early regulatory engagement approach as healthcare providers begin integrating structured AI-enabled systems into clinical workflows. ROSE operates within Botaniqal Clinics and is designed and delivered by Dr Sophia AI, an enterprise clinical intelligence platform developed to support healthcare providers seeking structured digital infrastructure within regulated...
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