The FDA should allocate more resources to assessing the efficacy and quality of software as a medical device (SaMD), on top of its safety evaluations. The call comes after a review of approvals found most were based on retrospective studies, with none of the high-risk devices assessed by prospective trials. Mayo Clinic is considering a more holistic approach to evaluating SaMD, involving a standard labelling schema documenting system characteristics, intended use and performance measures.
Over 1,000 Exposed ComfyUI Instances Targeted in Cryptomining Botnet Campaign – The Hacker News
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