Dexcom announced today that it broke ground on a new state-of-the-art manufacturing facility in Ireland. The San Diego-based continuous glucose monitor (CGM) maker announced plans to invest $325 million in Athenry last May. Breaking ground on the facility marks the first steps toward bringing more than 1,000 jobs to the area. The company expects the […]
Drug-Device Combinations
Insulet has new directors as former CEO is set to retire from board
Insulet announced today that it named a duo of new board directors with high-profile figures set to retire. Acton, Massachusetts-based Insulet appointed Flavia Pease and Timothy Stonesifer to its board. Former CEO Shacey Petrovic, along with Corinne Nevinny, intend to retire from the board in May. Petrovic spent more than seven years as CEO at […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
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. […]
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 […]
Dexcom submits new glucose sensor to FDA, expects launch this summer
Dexcom announced that it submitted its new Stelo glucose sensor to the FDA for review at the end of last year. The continuous glucose monitor (CGM) maker designed Stelo specifically for people with type 2 diabetes who do not use insulin. San Diego-based Dexcom designed Stelo for a 15-day wear with a cash-pay option. It […]
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 […]