Tag Archives: 670G

Medtronic CY Q1 ’20 (FY Q4 ’20) Earnings Update

Medtronic hosted its CY Q1 ’20 (FY Q4 ’20) earnings call and briefly discussed its diabetes business. Of note, Medtronic disclosed plans to launch a BLE-enabled 770G pump platform with remote updating functionality in the US ahead of the advanced hybrid closed-loop (AHCL) algorithm approval. Additionally, Medtronic will be presenting two AHCL data sets at the upcoming virtual ADA conference (June 12-16). Below, FENIX provides highlights and insights from the call.

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Medtronic Recalls 630G/670G Pumps After Thousands of Injuries and One Death

FDA’s medical device recalls website has been updated with a new recall alert regarding the Medtronic 600 series pump platform (630G and 670G products). According to the FDA website, the recall is based on a faulty or missing retainer ring which helps lock the insulin cartridge into place. Medtronic is said to have received over 26k complaints about the defect with at least 2,175 injuries and 1 patient death. Below, FENIX provides thoughts on the Medtronic insulin pump recall including insight as to why Tandem may be the big winner.

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Medtronic CY Q3 ’19 (FY Q2 ’20) Earnings Update

Medtronic hosted its CY Q3 ’19 (FY Q2 ’20) earnings call (press release) and provided a brief update to its diabetes business including the development of its 780G advanced hybrid closed-loop system which is projected to launch in FY H2 ’20 (CY late 2020/early 2021). Of note, Medtronic has also initiated a new “Next-Tech Pathway” program for pump upgrades (described below). Below, FENIX provides highlights and insights from the call.

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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 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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