The FDA labeled a recall of the Insulet (Nasdaq:PODD) 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, […]
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Medtronic wins CE mark for MiniMed 780G with Simplera Sync disposable, all-in-one CGM
Medtronic (NYSE:MDT) 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 […]
Abbott integrates FreeStyle Libre 2 Plus into Tandem’s automated insulin pump
Abbott (NYSE:ABT) 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 […]
Better Therapeutics, Glooko partner on digital diabetes management
Better Therapeutics and Glooko today announced a partnership to integrate technologies and enhance diabetes management. The partnership aims to integrate Better Therapeutics’ ApsyreRx digital behavioral treatment into Glooko’s diabetes management platform. Better Therapeutics designed AspyreRx to treat type 2 diabetes. The FDA authorized AspyreRx as a prescription digital therapeutic for diabetes in July. Palo Alto, […]
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 […]
Glucotrack has positive data for implantable continuous blood glucose monitor
Glucotrack (Nasdaq:GCK) announced today that it completed the first preclinical study of its implantable continuous blood glucose monitor (CBGM). Rutherford, New Jersey-based Glucotrack aimed to assess the implant technique and device safety in the study. Additionally, the study used a small sample size of sensors to determine device functionality. Despite no intent to conduct an […]
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 […]
BD inks $85M settlement over Alaris defect disclosure claims
BD (NYSE:BDX) 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 […]
Insulet applauds NICE guidance on hybrid closed loop insulin delivery
Insulet (Nasdaq:PODD) 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 […]