BD (NYSE:BDX) announced that it expanded its Class I voluntary recall for its Alaris Pump Module model 8100 infusion system. The expansion builds on a voluntary recall expanded earlier this year, informing customers of worst-case performance instances. Under certain cases, the pump, when used with a subset of compatible infusion sets, fails to perform as […]
Food & Drug Administration (FDA)
Dexcom to unveil new basal insulin titration module under FDA review, reports positive CGM data
Dexcom (Nasdaq:DXCM) today announced plans to unveil its Smart Basal integrated titration module for insulin delivery. The company plans to unveil Smart Basal and present new continuous glucose monitor (CGM) data at the 61st annual European Association for the Study of Diabetes (EASD) Conference in Vienna, Austria, this week. Dexcom’s CTO Girish Naganathan will speak […]
FDA identifies serious recall for Dexcom CGM mobile apps
The FDA identified a recent recall of smartphone apps for Dexcom (Nasdaq:DXCM) continuous glucose monitors (CGMs) as the most serious type. This recall involves correcting certain devices through a software update. It does not involve removing them from where they are used or sold. Serious recalls can lead to serious injury or death without correction. […]
Johnson & Johnson wins FDA nod for intravesical drug delivery tech
![The Inlexzo system. [Image courtesy of Johnson & Johnson]](https://www.drugdeliverybusiness.com/wp-content/uploads/2025/09/Inlexzo-JJ-2-1-150x86.jpg)
Johnson & Johnson (NYSE:JNJ) announced today that the FDA approved Inlexzo, its gemcitabine intravesical drug delivery system. The intravesical gemcitabine-releasing system, previously known as TAR-200, treats patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. A healthcare professional places TAR-200 into the bladder […]
Orange Biomed takes next step to bringing A1C test device to market
Orange Biomed announced a major milestone on its path to bringing a pocket-sized A1C analysis device to the market. The Seattle-based company received Good Manufacturing Practice (GMP) certification for in vitro diagnostic medical devices from Korea’s Ministry of Food and Drug Safety. This enables it to scale production of the pocket-sized portable diabetes testing device. […]
Ypsomed gets FDA nod for digital add-on for autoinjectors
Ypsomed announced that the FDA granted 510(k) clearance for SmartPilot, a digital connectivity add-on for its Ypsomate autoinjectors. The device transforms the YpsoMate into a connected system that automatically captures and transmits injection data. Ypsomed said this marks an important step toward digital health solutions that offer deeper insight into therapy use. The digital add-on […]
Medtronic gets FDA nods for MiniMed 780G with Abbott Instinct sensor, expansion to type 2
Medtronic (NYSE:MDT) announced today that the FDA granted two major approvals to broaden access to its MiniMed 780G system. First, the FDA granted clearance for its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC). This enables integration with a sensor made by Abbott, designed specifically through a collaboration between the medtech giants. Second, the […]
ICU Medical issues infusion pump software correction labeled serious by FDA
The FDA issued a notice labeling a recall of ICU Medical (Nasdaq: ICUI) infusion pumps as the most serious type of recall. This recall involves correcting certain devices. It does not require removing them from where they are used or sold. However, the FDA identified that the issue may cause serious injury or death if […]
Signos gets FDA green light for over-the-counter CGM for weight management
Signos announced today that it launched its FDA-cleared over-the-counter (OTC) glucose monitoring system for weight management. Palo Alto, California-based Signos integrated the Dexcom Stelo OTC continuous glucose monitor (CGM) with an AI-powered platform for deciphering unique metabolisms. It aims to help people see how food choices, timing, activity, stress and sleep affects their bodies in […]
Tandem picks up FDA clearance for 7-day infusion set
The FDA’s 510(k) database indicates that Tandem Diabetes Care (Nasdaq:TNDM) recently received clearance for an extended-wear infusion set. Tandem’s Capillary Biomedical (CapBio) subsidiary develops the SteadiSet Infusion Set. The wearable infusion set delivers insulin from an insulin pump to the body. Tandem — one of the largest diabetes tech companies in the world — develops the t:slim X2 and […]
