It’s been a long road for the Medtronic (NYSE:MDT) Diabetes unit to get its next-generation technology to market. For years, clinical data backed up the MiniMed 780G insulin pump with Guardian 4 sensor technology. Over the last year alone, The company hit an initial hiccup with an FDA warning letter related to its California Diabetes facility in 2021. […]
Drug Pumps
FDA clears basal-only insulin pod for type 2 diabetes from Insulet
Insulet (Nasdaq:PODD) announced today that it received FDA clearance for its Omnipod GO long-acting insulin delivery device. Omnipod GO, which received clearance for people with type 2 diabetes aged 18 or older, covers the basal-only insulin population. The target population typically takes daily injections of long-acting insulin. The first-of-its-kind, standalone, wearable insulin delivery system provides […]
FDA approves next-gen MiniMed 780G insulin pump from Medtronic
Medtronic announced that it received FDA approval for its MiniMed 780G system with the Guardian 4 sensor. The news — posted in the evening on April 21 — has MDT shares up more than 4% to $89.36 apiece in afternoon trading today. (MassDevice’s MedTech 100 Index is up slightly.) The positive news for the business […]
Fresenius Kabi recall of Ivenix infusion systems in Class I
The FDA this week said the Fresenius Kabi recall of some Ivenix infusion systems is Class I, the most serious kind. Fresenius Kabi is recalling some Ivenix infusion systems due to a leak in the system that allows fluid to enter the administration set loading area near the air detector. The leak could damage the […]
Fresenius Kabi wins Vizient contract for Ivenix infusion system
Fresenius Kabi this week announced its Ivenix infusion system was awarded an Innovative Technology contract from Vizient. Vizient members include more than half of all acute care hospitals in the U.S., and the Innovative Technology contracts are recommended after review and interaction with products submitted through the organization’s program. The contract sets terms for hospitals […]
11 diabetes tech startups you need to know
The diabetes technology space is one that’s always innovating. From continuous glucose monitoring to insulin pumps and the artificial pancreas, we’ve seen a lot. Companies are looking for all kinds of ways to make their mark in the world of diabetes. Newer offerings include digital health, software, coaching and more. For companies still in their […]
ViCentra now offers Kaleido insulin pump in the Netherlands
ViCentra recently announced that it made its Kaleido insulin pump system available for users in the Netherlands. Utrecht, the Netherlands-based ViCentra designed its insulin pump system as a small, light and accurate platform. The company says the system “lets people with diabetes live life on their own terms.” Kaleido features pulse technology that provides continuous […]
Vaccine patch maker Vaxess names former Sanofi exec as chief strategy officer
Vaxess Technologies, developer of a shelf-stable vaccine patch, announced today that it named Steve Bende as its new chief strategy officer. Bende previously served as global head of new products at Sanofi Pasteur. He led international, multifunctional teams at the pharmaceutical giant. That included assessing the commercial viability of potential new products. Prior to Sanofi, […]
Stevanato Group, Thermo Fisher to bring on-body drug delivery system to market
Stevanato Group (NYSE:STVN) today announced a collaboration with Thermo Fisher Scientific (NYSE:TMO) on drug delivery technology. The partnership aims to bring a fully integrated, on-body delivery system platform for subcutaneous administration to market. Stevanato Group said the device will be semi-reusable and provide micro-precision basal doses and full-content bolus injections. The company intends for the […]
Study backs Tandem Control-IQ artificial pancreas in young children
Tandem Diabetes Care (Nasdaq:TNDM) announced positive study data for its artificial pancreas using Control-IQ technology. The study demonstrated improved blood sugar control in children ages 2-6 with type 1 diabetes. It evaluated an artificial pancreas using the Tandem t:slim x2 insulin pump with Control-IQ technology. Results were published in the New England Journal of Medicine. […]
Insulet to replace Silicon Valley Bank in the S&P 500
S&P Dow Jones Indices announced that Insulet (Nasdaq:PODD) is set to replace Silicon Valley Bank in the S&P 500 index. The change becomes effective prior to the opening of trading on Wednesday, March 15. It adds Insulet to the index tracking 500 large companies listed on stock exchanges in the U.S. Silicon Valley Bank’s deletion […]