Dexcom (Nadsaq:DXCM) announced today that the FDA cleared its G7 15-day continuous glucose monitoring (CGM) system. The clearance covers people over the age of 18 years old in the U.S. It makes the G7, Dexcom’s latest-generation CGM, the longest-lasting wearable CGM, according to the company. San Diego–based Dexcom submitted its 15-day G7 CGM to the […]
Food & Drug Administration (FDA)
Dexcom receives FDA warning letter
Dexcom (Nadsaq:DXCM) announced today that it received a warning letter from the FDA following inspections of two company facilities. The letter followed inspections of the company’s plants in San Diego and Mesa, Arizona. San Diego is where Dexcom’s headquarters is located, while the company last year decided to move manufacturing out of San Diego to […]
Baxter warns on certain infusion pumps with missing screws
The FDA today issued a notice warning of a potential high-risk issue with certain Baxter (NYSE:BAX) Spectrum infusion pump systems. This communication came as part of the FDA’s pilot to enhance its medical device recall program. It follows a letter from Baxter recommending that customers remove certain Spectrum pumps from where they are used or sold. […]
FDA clears Tandem Diabetes Care’s next-gen automated insulin delivery algorithm for type 2 diabetes
Tandem Diabetes Care (Nasdaq:TNDM) announced today that the FDA cleared its Control-IQ+ automated insulin delivery algorithm for people with type 2 diabetes. San Diego-based Tandem already has FDA clearance for its AID algorithm for type 1 diabetes. It now joins Insulet in offering AID technology for the type 2 population. Medtronic plans to file with […]
Medtronic seeks to expand MiniMed 780G label to type 2 diabetes, submits new CGM to FDA
Third-quarter results for Medtronic (NYSE:MDT) today included a timeline for a planned label expansion for its automated insulin delivery platform. The medtech giant posted an overall revenue miss for the three months, despite growth in the Diabetes business. (Read more about the company’s third-quarter results at sibling site MassDevice.) Speaking on the company’s earnings call […]
Nasal vaccine devices: Design and regulatory need-to-knows
Nasal vaccine devices have the potential to offer more convenient and more effective protection against a variety of viruses. In 2024, the FDA approved a nasal spray as the first at-home influenza vaccination, allowing adults to vaccinate themselves or someone in their care without a needle jab or a trip to the pharmacy. Intranasal vaccines […]
FDA warns of potential missed alerts with smartphone-connected diabetes devices
The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical safety alerts. Devices like continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems can use smartphones to deliver alerts. Users can configure alert settings through applications on their phone. The FDA received medical […]
Fresenius Kabi warns on Ivenix infusion pump valves
The FDA said Fresenius Kabi told customers to remove its Ivenix large-volume infusion pumps from use for repair. This warning from the FDA comes as part of its Communications Pilot to Enhance the Medical Device Recall Program. The agency became aware of a potentially high-risk device issue and plans to keep the public informed on […]
Cardinal Health recalls certain insulin syringe component packs
The FDA deemed a recall of Cardinal Health (NYSE:CAH) insulin syringe luer lock packs as type I, the most serious kind of recall. This recall relates to the company’s Monoject U-100 mL insulin syringe luer lock with tip cap soft pack (extended conical tip). The device is used to administer insulin under the skin (subcutaneous) or […]
Medtronic wins FDA nod for new InPen app to support launch with Simplera CGM
Medtronic (NYSE:MDT) announced today that it received FDA clearance for its new InPen insulin delivery system application. The app features missed meal dose detection and paves the way for the launch of the company’s smart multiple daily injection (MDI) system. That system includes the recently FDA-cleared next-generation Simplera continuous glucose monitor (CGM). Medtronic’s smart MDI […]
