The company aims to start a pivotal trial this year, file for 510(k) clearance in 2027 and launch the device in 2028.

Please provide your email address to receive an email when new articles are posted on . Of 20 hospitals providing insulin algorithms, 60% stated which patients should initiate basal or nutritional ...

The Food and Drug Administration has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with Type 1 diabetes. These two devices, along ...

Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up its use to adults with Type 2 diabetes. The Control-IQ+ program—now with the added ...

CamDiab has added a new fully closed-loop feature, CamAPS Liberty, to its world-leading, interoperable CamAPS FX app. A closed-loop system is where a diabetes sufferer uses an insulin pump plus a ...

MILPITAS, Calif.--(BUSINESS WIRE)--Bigfoot Biomedical (Bigfoot), a leader in developing intelligent connected injection support systems, today announced the acquisition of a reinforcement learning ...

Although automated insulin delivery systems have gained traction in type 1 diabetes, further research is needed to determine the feasibility of using such systems for patients with type 2 diabetes.

The US Food and Drug Administration (FDA) has expanded the indication for Tandem Diabetes Care’s Control-IQ+ Technology to include people with type 2 diabetes (T2D). The next-generation Control-IQ+ ...

Please provide your email address to receive an email when new articles are posted on . The FDA cleared the iLet ACE insulin pump and iLet dosing decision software for people with type 1 diabetes. The ...

CHICAGO -- A once-weekly basal insulin had similar safety and efficacy to a daily insulin option, a series of trials from the phase III QWINT development program found. In QWINT-1, there was a similar ...