R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.


First Artificial Pancreas receives FDA Approval

Upon my nightly adventures of surfing the World Wide Web I came across this article on the Popular Science website announcing the FDA’s approval of the Medtronic MiniMed 530G Insulin pump, praisingly dubbed the first artificial pancreas. The Medtronic device was officially approved by the FDA on September 26, 2013 through the Premarket Approval (PMA) pathway. According to the FDA Approval Letter the MiniMed 530G System is intended for continuous delivery of basal Insulin (at user selectable rates) and administration of Insulin boluses (in user selectable amounts) for the management of Diabetes mellitus in persons, sixteen years of age and older, requiring Insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G System can be programmed to automatically suspend delivery of Insulin when the sensor glucose value falls below a predefined threshold value.

Mobile Medical Applications: Falling Star?

I think it's high time we start profiling a few applications that have been approved for use by the FDA, discuss their functionality, and potentially profile the impending issues they may encounter.

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