Category Archives: Insulin Delivery

Insulet Omnipod DASH Pump Receives Interoperability Designation

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).

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Farxiga HF Fast Track Designation; New Novo/Medtronic and Sanofi/Abbott Partnerships

With the start of the 2019 EASD conference, a series of diabetes drug and device-related press releases have been observed including connected care partnerships between Novo/Medtronic and Sanofi/Abbott. Additionally, AstraZeneca announced that FDA granted Fast Track designation for dapagliflozin in worsening heart failure. Below FENIX insights and context from each respective announcement.

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Medtronic CY Q2 ’19 (FY Q1 ’20) Earnings Update

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.

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Medtronic Extended Wear Infusion Set

Medtronic announced it received Investigational Device Exemption (IDE) from FDA to initiate in-human studies of a new extended wear infusion set. According to the press release, the trial will evaluate the new infusion set for up to 7 days in 150 T1DM subjects using the 670G hybrid closed-loop system. The trial has not yet been observed on CT.gov. Below, FENIX provides thoughts on the new Medtronic infusion set initiative.

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BD Swatch pump 510(k) withdrawn; BD CY Q2 ’19 (FY Q3 ’19) Earnings Update

BD hosted their CY Q2 ’19 (FY Q3 ’19) earnings call (press release) and provided a brief update on their diabetes business unit including the 510(k) withdrawal of their Swatch pump for T2DM. Below, FENIX provides further details on the Swatch pump 510(k) withdrawal and insight into its impact on the T2DM patch pump segment.

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Insulet Q2 ’19 Earnings Update

Insulet hosted its Q2 ’19 earnings call and provided updates to its commercial and pipeline activities including the Omnipod Horizon hybrid closed-loop development. Below are highlights and insights from the call.

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Tandem Q2 ’19 Earnings Update

Tandem Diabetes Care hosted its Q2 ’19 earnings call and provided updates to its t:slim pump business. Additionally, Tandem announced that all software updates through YE 2020 will be provided free to users with in-warranty pumps. Below, FENIX provides highlights and insights from the call.

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Medtronic Files CGM for Non-Adjunctive Claim

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.

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