After announcing positive results at the American Diabetes Association conference and an expanded FDA approval for its insulin pump delivery system, Tandem Diabetes Care’s CEO outlines its path forward.
With new study results presented at this week’s virtual American Diabetes Association (ADA) meeting followed by approval from US regulators to expand the indication for its t:slim X2 insulin pump with Control-IQ technology system, Tandem Diabetes Care Inc. is hoping for brighter days ahead.
The San Diego,CA-based insulin pump maker announced on 17 June that the US Food and Drug Administration has approved an expanded indication for its t:slim X2 insulin pump with Control-IQ...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
