Huma Therapeutics has been granted Class II clearance from the FDA ... Device (SaMD) disease management platform, dramatically expanding the range of services it can deliver. Class II approval ...
has been approved by the FDA. Brisbane, Australia-based ResApp has claimed a 510(k) clearance for SleepCheckRx as a prescription-only digital therapy in the software-as-a-medical device (SaMD ...
independence and transparency in Canada’s drug approval process. COVID-19 has exacerbated a backlog of domestic and foreign drug manufacturing inspections that the FDA is still too short-staffed ...
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