FDA Approves Medtronics' Artificial PancreasFriday, September 27, 2013
The FDA has approved the first artificial-pancreas system in the United States, a device developed at Medtronic Inc.’s Northridge facility, the company announced on Friday.
The MiniMed 530G is the first insulin pump in the country that can automatically stop insulin delivery when blood sugar drops below a preset level. It includes a feedback loop between the insulin pump and a blood-sugar monitor - a major step toward making a completely automatic artificial pancreas.
The 530G was developed at Medtronic’s lab in Northridge, where about 1,500 employees work on the project in both research and manufacturing. Medtronic, based in Minneapolis, has sold the system in Europe for four years.
The company said it will ramp up production immediately to prepare for a launch of the MiniMed 530G in the next several weeks, following the U.S. Food and Drug Administration approval.
“The MiniMed 530G with Enlite can help people gain better control of their diabetes versus multiple daily injections,” said Katie Szyman, president of the diabetes business at Medtronic, said in a statement. “We are committed to advancing closed-loop algorithms, continuous glucose monitoring and insulin-delivery technologies to bring new artificial pancreas systems to market.”
The company noted that it is working on a next-generation insulin pump that will fully replicate the function of a pancreas by automatically monitoring glucose levels and delivering insulin, requiring minimal to no interaction by the patient.