Browse by topic
Subscribe to our news

Diabetes

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.
Read Now

iPhone

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.
Read Now
1

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!