Medtronic's Artificial Pancreas Wins FDA Approval

Qmed Staff

September 27, 2013

2 Min Read
Medtronic's Artificial Pancreas Wins FDA Approval

Medtronic landed FDA approval for its artificial pancreas, dubbed the MiniMed 530G. The novel device can automatically stop delivery of insulin when a patient's glucose levels dip to dangerous levels. Previous devices emitted an alarm to alert patients whose blood sugar levels were too low. According to financial analyst Danielle Antalffy of Leerink Swann Research, the news could reinvigorate Medtronic's diabetes sales in the U.S. in the remainder of 2013.

According to the company, commercialization of the MiniMed 530G will take place over the coming weeks. The device is intended for use on patients over the age 16 who are diagnosed with diabetes. However, Medtronic will pursue an additional post-commercialization study on the use of the device in children over age two.


The new artificial pancreas has several advantages for patients suffering from diabetes. Since the new MiniMed 530G works with Medtronic's Enlite sensor, it can detect blood glucose levels with higher accuracy than earlier systems. On top of this, the system includes Medtronic's Threshold Suspend technology, which can automatically stop the delivery of insulin as determined by a preset threshold.

If a patient is unconscious or sleeping, an auto-stop mechanism will activate after approximately 120 minutes (assuming that a preset threshold for insulin has been met). With the device, patients can control their diabetes without the need for multiple injections.

"We're excited to bring yet another important 'first' to the United States. The MiniMed 530G with Enlite can help people gain better control of their diabetes versus multiple daily injections," stated Katie Szyman, president of Medtronic's Diabetes segment. "We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market."

The Enlite serter was a gold winner in the 2013 Medical Design Excellence Awards.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like