The FDA’s recall database today posted notices related to a Class I recall for continuous glucose monitor (CGM) components made by Dexcom (Nasdaq:DXCM). Dexcom’s recalls relate to its Dexcom One and One+ offerings and the G6 and G7 CGMs. The One and One+ systems, which are mainly the company’s commercial CGM offering outside the U.S., feature […]
FDA
Baxter issues serious correction for large-volume infusion pump
The FDA has warned of a serious potential issue with Novum IQ large-volume infusion pumps made by Baxter (NYSE:BAX). Baxter’s recall of the system involves updating instructions for use. It does not require removal from use or sale. However, the FDA identified it as the most serious type of recall, carrying the risk of injury […]
Smiths Medical warns on trio of infusion pump issues
The FDA issued three notices identifying warnings sent out by ICU Medical‘s Smiths Medical unit related to infusion pump problems. Smiths Medical warned of issues with some of its CADD-Solis and CADD-Solis VIP ambulatory infusion pumps. The CADD-Solis pump offers utility in hospital or outpatient settings, delivering pain therapies. CADD-Solis VIP pumps are intended for […]
Tandem Diabetes Care subsidiary earns new FDA clearance for insulin infusion set
Tandem Diabetes Care (Nasdaq:TNDM) shared in an SEC filing that its Capillary Biomedical (CapBio) subsidiary won FDA 510(k) clearance for a new infusion set. The company won clearance for its SteadiSet Infusion Set, according to an SEC Form 8-K. It’s a wearable infusion set that delivers insulin from an insulin pump to the body. San Diego-based […]
Medtronic wins FDA nod for new Simplera Sync CGM with MiniMed 780G
Medtronic (NYSE:MDT) announced that the FDA approved its Simplera Sync continuous glucose monitor for use with the MiniMed 780G. Approval provides more options for users of the automated insulin delivery (AID) system, which can also work with the Guardian 4 sensor. Simplera Sync, a disposable, all-in-one sensor requires no fingersticks or overtape. It works with SmartGuard […]
Dexcom wins FDA nod for 15-day CGM
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 […]
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 […]
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 […]
