Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump.
The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It also has a closed-loop version under development to follow. That version features an embedded algorithm that requires Embecta to run a clinical study.
Embecta describes the pump as convenient and discreet, featuring a 300-unit insulin reservoir. Embecta designed it to lighten the burden of managing diabetes while improving user outcomes. Colleen Riley, the company’s CTO, said the pump design is informed by “the unique needs” of people with type 2 diabetes and their healthcare providers.
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