One caveat: Medtronic got a warning letter from the FDA only a few weeks ago related to manufacturing processes of their Paradigm Insulin Infusion Pumps (which are used in this system) at their facility in Northridge, Calif. The pumps had been recalled in June because they were malfunctioning and delivering either too much or not enough insulin, and the FDA found the company was not doing enough to verify that the failure wouldn't happen again. The company said in the press release accompanying the product approval that it had "already addressed many of the observations noted in the warning letter and is committed to resolving the remaining observations as quickly as possible."