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AI clinical decision support enters TGA regulatory pathway

9 March 2026
By Pulse+IT
Botaniqal Clinics Australia has submitted its AI-enabled clinical decision support software, ROSE, to the Therapeutic Goods Administration for registration as Software as a Medical Device (SaMD). Botaniqal says the submission marks an early regulatory engagement approach as healthcare providers increasingly integrate structured AI-enabled systems into clinical workflows. ROSE operates within Botaniqal Clinics and is delivered […]

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