We are almost through to the end of this year and we are all looking forward to new diabetes technologies coming out in 2021! Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its MiniMed… Medtronic’s Upcoming Personalized Closed Loop System The second product in development is … As for the ongoing impact of COVID-19 on new business for these companies, findings from a survey of endocrinologists from analysts at Stifel this week suggested a rebound for CGM and in patient visits, but March and April declines in pump prescriptions "seem largely unchanged." MiniMed 780G: This second-gen automated insulin delivery system will add automatic correction boluses for high blood sugars, in addition to the current basal-rate-only adjustment in the MiniMed 670G. The company’s initial target of April 2020 appears overly ambitious, since the 780G pivotal trial isn’t expected to complete until mid-year. Medtronic plans to incorporate the technology into a future personalized closed loop (PCL) system for diabetes management, which received breakthrough device designation from FDA in February. Insulet just restarted its pivotal study of Horizon, meant to support U.S. approval and a launch in the first half of 2021. on Medtronic’s MiniMed 780G with Artificial Pancreas Capabilities Cleared in EU. June 18th, 2020 Discover announcements from companies in your industry. June 18th, 2020 Medgadget Editors Informatics, Medicine, Telemedicine. Welcome to the MiniMed™ 780G system – webcasting event video. As many will be aware, at ADA Scientific Sessions this week, Medtronic announced the the outcomes of a number of trials of the 780G, including two that compared the 780G with either the 640G or the 670G, alongside the European approval for the device, while Omnipod also announced the outcomes of one of their pre-pivotal trials on the Omnipod 5 (née “Horizon”) system. The 780g has just wrapped up clinical trials and results are set to be released in July. controller at the end of 2019. The last day to place an order is 12/1/20. The warranty ran out so I began using the TSlim X2 in January. In the world of diabetes tech, last year's ADA meeting was an important debut for NIH clinical trial data on Tandem's Control-IQ closed loop algorithm, which went on to obtain De Novo authorization from FDA as the first interoperable automated glycemic controller at the end of 2019. The second will examine the Guardian CGM sensor among 460 adult participants aged two years to 80 years. Continuous glucose monitoring (CGM) technology is an incredibly useful tool that can improve diabetes management, and the release of Dexcom’s new CGM, the G7 is certainly one to look out for. The session will also highlight a small pre-pivotal study of Insulet's tubeless smartphone-controlled automated insulin delivery system, dubbed Horizon, which is slated to integrate with both Dexcom and Abbott CGMs and expected to come to market in the first half of 2021. Thanks so much Dennis. Pivotal trial currently underway, US launch likely in mid-2020 for adults first (14+ or 18+ years). The first will involve a Bluetooth-enabled MiniMed 780G advanced hybrid closed loop system, and will enroll up to 350 adult and pediatric patients. Will IBM’s reported desire to sell Watson cast a shadow over big tech’s healthcare ambitions? Non-adjunctive status means that the sensor is accurate enough to safely and consistently calculate an insulin dose for meals and to correct high blood sugar levels. I have compiled a set of final tips/observation for those planning to get the 670G and use Auto Mode based on my 2 year experience with the pump and Auto Mode. MINIMED™ 670G SET THE BAR… MINIMED™ 780G AND PCL AIM TO RAISE THE BAR 8.2% 7.7% 7.7% 7.9% MiniMed™ 670G1,2 72% Goal: TIR >80% Advanced Hybrid Closed Loop (MiniMed™ 780G) Building on data & learnings from MiniMed™ 670G with pipeline technology Goal: TIR >85% Personalized Closed Loop (PCL) 1. Eligibility dates subject to change. Experimental Infusion Set Aims to Address Patient Burden with Comfort and Convenience Features for Insulin Pump Therapy. The free newsletter covering the top industry headlines, Kendall Davis/Industry Dive/MedTech Dive, data from Marc Nozell, clinical trial data on Tandem's Control-IQ closed loop algorithm, which went on to. U.S. pivotal safety study and a trial comparing the advanced hybrid closed loop system to its 670G system. The system, indicated to be used by patients with type 1 diabetes between ages 7 and 80, automatically delivers both basal insulin and correcting boluses every five minutes, if necessary. AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval. The Medtech4 Europe project has reached the end of its first phase, GenesisCare Brings Western North Carolina Cancer Patients Elekta Versa HD™ Technology, Predicting medical device safety recalls using publicly available data, Hospital admissions not linked to COVID-19 plunged in fall, especially in Midwest, BD drug-coated balloon falls short at FDA panel, signaling likely rejection. Considering that Medtronic plans to release the MiniMed 780G this year, I have decided I might as well wind up my blog on my experience with the MiniMed 670G and Auto Mode. Finally, the company said Saturday that it has kicked off two new diabetes trials. Medtronic plans a U.S. launch of 780G later in its fiscal year. © Medgadget, Inc. All rights reserved. Medtronic MiniMed 780G – expected mid-2020. Medtronic expects to release this new product in the second half of 2020. Twitter. My overall take is that people are happier with Tandem and Dexcom than the 670g. Air pressure range is from 700 hPa to 1060 hPa (10.2 psi to 15.4 psi). In 2018 the latter became the first FDA-approved hybrid closed loop system to monitor glucose and automatically adjust insulin delivery. Minimed 670G (Hybrid Closed Loop) ... Medtronic is launching the 770G first as a separate device, prior to the eventual release of the full-featured 780G. 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The MiniMed ™ 770G system, sometimes referred to as a hybrid closed loop system, automatically adjusts delivery of basal (background) insulin based on CGM sensor glucose values. DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it received investigational approval from the U.S. Food and Drug Administration (FDA) to proceed with a pivotal trial for a new … This is expected to enable a higher time-in-range of over 80%, with a lower average glucose of 135 mg/dl. A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA. I feel I have given the X2 a good run, but I am considering switching to the 670G or even waiting it out till end of 2020 for the 780G which is supposed to have Bluetooth for iPhone. The MiniMed™ 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. Thanks most kindly for your help. 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