Diabetes Researchers Say FDA Is Slowing Artificial Pancreas Efforts
This article was originally published in The Gray Sheet
Executive Summary
Developers of "artificial pancreas" devices for treating type 1 diabetes may gain insight from new FDA draft guidance on clinical trial design, but patients and advocates say the agency is standing in the way of greater advances in the space.
You may also be interested in...
Medtronic Sees Long-Awaited Approval Of MiniMed 530G As A Big Step In Artificial Pancreas “Journey”
Medtronic recently announced FDA approval of its MiniMed 530G low-glucose-suspend insulin pump, the first system approved in the U.S. that can automatically stop insulin delivery when blood glucose levels fall to a pre-set level.
News Briefs: Medtronic’s First-Gen Artificial Pancreas Approved; CMS Removes Bariatric Surgery Requirements
FDA approves Medtronic’s MiniMed 530G system, making it the first system in the U.S. that can automatically suspend insulin delivery to people with diabetes. CMS removes bariatric surgery facility certification requirements. More news.
Regulatory News In Brief
FDA issues final guidance on IDE and PMA requirements for artificial pancreas devices. CDRH plans Office of Compliance reorganization. More regulatory news.