A trial has been posted on CT.gov evaluating a new Medtronic extended wear infusion set (EWIS). Recall, Medtronic recently announced it had received an IDE from FDA to initiate EWIS development. Below, FENIX provides thoughts on the trial in the context of a future infusion set/CGM combination.
On the second day of EASD, 7 key press releases and one new clinical trial were observed across diabetes drugs and devices. Below FENIX provides insights and context from each respective announcement.
Medtronic hosted its CY Q2 ’19 (FY Q1 ’20) earnings call and provided a brief update to its diabetes business including the projected launch of its 780G advanced hybrid closed-loop system in FY H2 ’20 (CY late 2020/early 2021). Below, FENIX provides highlights and insights from the call.
Medtronic announced it has filed a PMA with FDA seeking a non-adjunctive (insulin dosing) claim for the Guardian Sensor 3 as part of the 670G platform. The timing is consistent with Medtronic’s CGM roadmap from its 2019 ADA investor presentation. Below, FENIX provides thoughts on the filing including the curious observation that Medtronic chose to file as part of the SAP system and not the standalone Guardian Connect CGM.
The DreaMed FDA approval for its Advisor Pro algorithm now empowers Glooko to compete with Medtronic’s CareLink across the patient and provider customer segments. Below, FENIX provides insight into Glooko’s enhanced position to compete with Medtronic’s CareLink in diabetes decision support services.