The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
Drug Pumps
Diabetes unit continues to power growth at Abbott with Lingo coming to U.S. ‘soon’
With continued progress on established platforms, new acquisitions and new products, Abbott has high expectations for its Diabetes business. Speaking at the J.P. Morgan Healthcare Conference, CEO Robert Ford highlighted diabetes as a key area for near-term growth. Specifically, in the presentation transcribed by SeekingAlpha, Ford said he expects the FreeStyle Libre continuous glucose monitor […]
Embecta submits insulin patch pump for FDA clearance
Embecta (Nasdaq:EMBC) announced today that it submitted a 510(k) premarket filing to the FDA for its proprietary insulin patch pump. The Parsippany, New Jersey-based BD Diabetes spinoff developed a proprietary, disposable pump for people with type 2 diabetes. The company provided analysts with some details on the makeup of the open-loop system earlier this year. It […]
Insulet has a Class I recall for the Omnipod 5 Android App
The FDA labeled a recall of the Insulet Omnipod 5 App for Android smartphones as Class I, the most serious kind. Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, 2023. […]
Medtronic wins CE mark for MiniMed 780G with Simplera Sync disposable, all-in-one CGM
Medtronic announced today that it received CE mark approval for its MiniMed 780G system with Simplera Sync. Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM), eliminates the need for fingersticks and overtape. It features an improved user experience at half the size of previous Medtronic sensors with a simple, two-step insertion process. MiniMed 780G, […]
Abbott integrates FreeStyle Libre 2 Plus into Tandem’s automated insulin pump
Abbott and Tandem Diabetes Care (Nasdaq:TNDM) today announced the integration of FreeStyle Libre 2 Plus CGM into the t:slim X2 insulin pump. This marks the first automated insulin delivery system to integrate the newly available Abbott FreeStyle Libre 2 Plus sensor. The FDA cleared the updated Abbott continuous glucose monitor (CGM) for use with automated insulin […]
UK receives funding for automated insulin pump rollout this year
Following new government guidance, the UK’s National Health Service (NHS) has plans to roll out automated insulin delivery systems. Last month, the National Institute for Health and Care Excellence (NICE) issued guidance supporting automated insulin delivery for type 1 diabetes. NICE published guidance recommending hybrid closed-loop systems for eligible people with type 1 diabetes in […]
PharmaSens submits insulin patch pump for FDA approval
PharmaSens announced today that it submitted an application for FDA approval for its Niia Essential insulin patch pump system. FDA submission follows the pump’s recent ISO 13485 certification for the Switzerland-based company. This encompassed the entire process of design, development, manufacturing and distribution for insulin infusion pumps and accessories. Niia Essential, the first of three […]
The 10 biggest diabetes tech stories from 2023
It was another banner year for diabetes technology, with regulatory approvals, product launches and M&A all playing their part. Diabetes technology’s impressive 12 months marked a major trend across medtech as a whole, too. In 2022, the diabetes space saw plenty of progress from some of its biggest names and this past year proved no different. […]
BD inks $85M settlement over Alaris defect disclosure claims
BD announced that it filed settlement documents for an $85 million agreement to resolve claims regarding its Alaris infusion pump technology. The Alaris system has been much maligned over the past few years. Its troubles date back to a Class I recall in early 2020. The recall, which centered around multiple system errors, software errors, […]
Insulet applauds NICE guidance on hybrid closed loop insulin delivery
Insulet supports new National Institute for Health and Care Excellence (NICE) guidance supporting automated insulin delivery for type 1 diabetes. NICE published guidance recommending hybrid closed-loop systems for eligible people with type 1 diabetes in England and Wales. Hybrid closed-loop systems, like the Insulet Omnipod 5, deliver insulin automatically based on calculations from glucose monitors. […]