A series of cardiometabolic-related news items has been observed by Medtronic, Roche, Viking Therapeutics, Zealand Pharma, Sanofi, Merck, and Esperion. Below, FENIX provides highlights and insights for the respective news items.
Tandem announced it received FDA clearance for Control IQ as the first “interoperable automated glycemic controller device” (denoted as iAGC below and previously described as “iAlgorithm” by FENIX). Notably, FDA also issued a press release regarding the approval. With Control IQ’s approval, FDA has established new special controls for the final component of interoperable systems. Dexcom’s G6 CGM was the first interoperable CGM (iCGM), and Tandem’s t:slim X2 was the first alternate controller enabled pump (ACE pump). Below, FENIX provides insights on the Control IQ approval in the context of future interoperable systems in development as well as thoughts on how JDRF’s new plea to UHC could help Tandem expand access.
Insulet announced it received FDA clearance for the “Omnipod DASH ACE Pump” to be classified as an alternate controller enabled (ACE) pump which allows for integration with other interoperable components (e.g. iCGM and eventually an “iAlgorithm” although no “iAlgorithms” are approved as of yet). Recall, ACE is FDA’s new designation for pump interoperability which requires manufacturers to meet a set of special controls. Below, FENIX provides thoughts on the Omnipod ACE pump designation including read-through to Insulet’s closed-loop developments (Omnipod Horizon and Tidepool Loop).