Singapore’s Health Sciences Authority (HSA) is seeking feedback on draft guidelines released on standalone medical mobile applications and qualification of clinical decision support software (CDSS). Based on the International Medical Device Regulators Forum’s (IMDRF)...
There is no doubt that medical devices are vital tools that not only enhance quality of life, but also save lives. From invitro diagnostic devices (IVD) like HIV blood diagnostic tests and blood glucose self-testing to software as a medical device (SaMD) that have...
The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as...
A wide variety of medical technology devices are being more rapidly reviewed and tested for patient use through the U.S. Food and Drug Administration (FDA) Breakthrough Device List. Among the list of innovations are two breast cancer diagnostic tests along...
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