Artificial Pancreas Guidance Allows For More Flexibility In Trial Design
This article was originally published in The Gray Sheet
FDA’s final guidance on the design and clinical study of artificial pancreas systems broadens the study endpoints permissible for the devices, which aim to “close the loop” in the treatment of type 1 diabetes.
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CDRH has formed a close working partnership with Medtronic to facilitate quick approval for a next-generation insulation pump-glucose monitor, offering an illustration of what the center’s future plans might be for addressing devices with breakthrough potential.
The first fully functional artificial pancreas for patients with diabetes could be ready for regulatory submission in the next few years. Medtronic has achieved notable success in this area to date, but positive clinical studies have put J&J in a good position as well, and the medical community is watching closely as the major developments in this groundbreaking endeavor continue to move forward.