BD’s Insulin Infusion Set Wins FDA 510(k) Clearance
BD Medical plans to launch its new insulin infusion set with BD FlowSmart technology for type 1 diabetes during fiscal year 2016, following the receipt of FDA 510(k) clearance. The device is BD’s first diabetes product in the infusion set category.
The BD FlowSmart technology consists of a side-ported catheter designed to improve insulin flow and limit the number of flow interruptions that occur when there is a continuous rise in pressure lasting at least 30 minutes, the devicemaker says.
About two thirds of insulin pump users experience flow interruptions that are undetected by their device’s occlusion alarm system, BD notes. A clinical study found that patients who use the company’s infusion set experience significantly fewer flow interruptions, the company adds.
The product received Health Canada approval earlier this year and is currently awaiting CE mark approval. — Jason Scott