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 ...

See FD&C Act, Section 522. While obtaining FDA approval for SaMD is a complex process, proper preparation, thorough testing, accurate risk assessment (Class I-III), and ongoing monitoring ...

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 ...

“Phasing out animal testing is a necessary and long-overdue step toward modernizing the FDA’s approval process,” Rogers told Healio. “That said, while removing this requirement could help ...

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 ...