News Briefs: Medtronic’s First-Gen Artificial Pancreas Approved; CMS Removes Bariatric Surgery Requirements

Medtronic PLC announced Sept. 27 FDA approval of its MiniMed 530G low-glucose-suspend system. It is the first system in the U.S. that can automatically stop insulin delivery when sensor values reach a pre-set lower level and when the patient doesn’t respond to the threshold suspend alarm, the company said in a release. Medtronic plans to launch the system in the coming weeks. The MiniMed 530G system incorporates the new Enlite sensor, which Medtronic says is its most accurate and comfortable continuous glucose sensor, with a 31 percent improvement in overall accuracy from the previous generation. In June, the New England Journal of Medicine published positive data for the threshold-suspend pump system. (See Also see "Positive Data For Threshold-Suspend Feature Of Medtronic Insulin Pump" - Medtech Insight, 1 July, 2013..) FDA approved the system for use in diabetics ages 16 and older, and the agency is requiring the firm to do a post-approval study examining children ages two and older. Also as a condition of approval, Medtronic will engage in direct patient follow-up and make manufacturing accommodations in response to a warning letter sent to the firm Sept. 19. (See Also see "FDA Audit Slows Down Medtronic Launch Plans For Low-Glucose-Suspend Diabetes System" - Medtech Insight, 27 May, 2013..)

Patient advocates, academics and clinicians have been calling for the agency to approve an artificial pancreas system in the U.S. for years. (See Also see "Diabetes Researchers Say FDA...