embecta Announces FDA Clearance of its Disposable Patch Pump for Insulin Delivery Informed by the Unique Needs of People with Type 2 Diabetes

Core Insights - Embecta Corp has received FDA 510(k) clearance for its disposable insulin delivery system, aimed at adults with diabetes, including both T1D and T2D [1][2] - The system features a tubeless patch pump with a 300-unit insulin reservoir, designed specifically for T2D patients transitioning from multiple daily injections to pump therapy [1][2] - The patch pump can deliver adjustable basal and bolus insulin for up to three days, addressing the higher daily insulin needs of T2D patients [2][4] Product Features - The disposable insulin delivery system includes a wearable patch pump that can accommodate higher insulin requirements, with 64% of T2D adults able to use the 300-unit reservoir for three days, compared to only 38% with a 200-unit reservoir [2] - The system is equipped with a locked-down controller featuring Bluetooth technology and a color touchscreen for a simplified user experience [3] Strategic Importance - Achieving FDA clearance is a strategic priority for Embecta, reflecting its commitment to improving the lives of people with diabetes [2] - The company plans to develop a closed-loop version of the patch pump, which will include an insulin-dosing algorithm for future FDA submission [4] Company Background - Embecta is a global diabetes care company with a 100-year legacy in insulin delivery, focusing on innovative solutions to empower individuals with diabetes [6]