On December 22, 2021, Medtronic published a news release that the US Centers for Medicare and Medicaid Services (CMS) is extending coverage for all adjunctive as well as non-adjunctive continuous glucose monitors (CGMs). Previously, Medtronic CGMs were excluded by Medicare because they were not rated as adjunctive. This term simply means that treatment decisions could be made on the CGM reading by itself. This decision takes effect 60 days after official publication.
This is great news for Med-T CGM users on Medicare!
On the negative side, Medtronic announced on Dec 15 it received a warning letter from the U.S. Food and Drug Administration (FDA) on December 9 for the company’s Northridge, California, facility, the headquarters for its Diabetes Business. The warning letter was issued following an inspection that concluded in July 2021 related to recalls of the MiniMed™ 600 series insulin infusion pump, and a remote controller device for MiniMed 508 and Paradigm pumps.
The 600 series recall is about the clear ring, something that has been on recall for several months. The keyfob for the 500 relates to cyber security risks, also something that was recalled many months ago.
rickI am a Medtronic ambassador. My opinions are my own. They did not pay me to say nice things. OK, they sent me a shirt and a cup but even I am more expensive than that.
The 500 series pump is not being recalled at all. This relates only to the key fob and in that regard they have been under recall for years. The advisory letter is one dealing with how Medtronic handled the two recall procedures. It is true that Medtronic would like to get them back, but the issue with the letter is how the company dealt with recalls and notifications.
I have not read the letter so this is just what I understand. So yes they wish to communicate that the Keyfob has a potential security issue. This has been known for several years.
I am a Medtronic ambassador. My opinions are my own. They did not pay me to say nice things. OK, they sent me a shirt and a cup but even I am more expensive than that.