Sam Brusco, Associate Editor01.09.24
Embecta has submitted a 510(k) premarket filing for a proprietary disposable insulin patch pump to the U.S. Food and Drug Administration. The company also plans to develop a closed-loop version with an insulin-dosing algorithm for future FDA submission.
N.J-based Embecta is a spinoff of BD (Becton, Dickinson and Co.) with a 100-year legacy in insulin delivery. The pump is convenient and discreet according to the company, and features a 300U insulin reservoir. Embecta chief technology officer Colleen Riley said the pump’s design reflects the unique needs of people with type 2 diabetes.
Chief medical officer Henry Anhalt, D.O. added that nine of ten people who have diabetes live with type 2 diabetes, stressing that current automated insulin delivery solutions were designed for type 1 diabetes patients.
"Since we became an independent company in April 2022, our team has been working diligently on our priorities, which include investing for growth—notably in the development of a patch pump," said Devdatt (Dev) Kurdikar, embecta CEO. "The 510(k) submission of our patch pump to the FDA is an important step in the advancement of our strategic priorities, and we look forward to working with the FDA to seek clearance for a product that we believe has the potential to positively impact type 2 diabetes management for many people."
Learn more about technologies to manage diabetes here!
N.J-based Embecta is a spinoff of BD (Becton, Dickinson and Co.) with a 100-year legacy in insulin delivery. The pump is convenient and discreet according to the company, and features a 300U insulin reservoir. Embecta chief technology officer Colleen Riley said the pump’s design reflects the unique needs of people with type 2 diabetes.
Chief medical officer Henry Anhalt, D.O. added that nine of ten people who have diabetes live with type 2 diabetes, stressing that current automated insulin delivery solutions were designed for type 1 diabetes patients.
"Since we became an independent company in April 2022, our team has been working diligently on our priorities, which include investing for growth—notably in the development of a patch pump," said Devdatt (Dev) Kurdikar, embecta CEO. "The 510(k) submission of our patch pump to the FDA is an important step in the advancement of our strategic priorities, and we look forward to working with the FDA to seek clearance for a product that we believe has the potential to positively impact type 2 diabetes management for many people."
Learn more about technologies to manage diabetes here!