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 […]
Food & Drug Administration (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 […]
Go-Pen ApS wins FDA nod for user-filled insulin pen
Go-Pen ApS announced recently that it received FDA 510(k) clearance for its Go-Pen cost-effective, user-filled insulin pen. Copenhagen, Denmark-based Go-Pen ApS says that, despite advances in diabetes technology, approximately one-third of insulin users worldwide (more than 20 million people) rely on traditional vials and syringes due to cost and access limitations. According to a news […]
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 […]
Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon. It marks the second major regulatory milestone for Orchestra BioMed in just a week. The company last week picked up FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy. FDA IDE enables the company to […]
Medtronic submits interoperable insulin pump to FDA to advance collaboration with Abbott
Medtronic (NYSE:MDT) announced today that it submitted 510(k) applications to the FDA seeking clearance for an interoperable insulin pump. Clearance would enable system integration with a continuous glucose monitor (CGM) sensor based on Abbott’s most advanced platform. This marks the latest development in a landmark collaboration between the two medtech giants. Last summer, the companies […]
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 […]
