Dive Brief Abbott has recalled a small number of Freestyle Libre 3 sensors distributed in the U.S. in the first half of May, the company said Wednesday. Internal testing found a subset of three lots of the continuous glucose monitor (CGM) sensors may provide incorrect high glucose readings, the company said. The false readings could lead to incorrect treatment decisions, such as taking insulin when not required. Abbott is sending free replacements to affected users. A spokesperson for Abbott said via email the recall “may impact less than 1% of Libre 3 users in the U.S.” but did not specify the number of devices affected when asked. Dive Insight Abbott’s Freestyle Libre 3 CGM product consists of a wearable sensor, a reader and an app. The recall affects only the sensor component. Abbott has “received a small number of reports from consumers regarding the issue,” the spokesperson wrote. The company ...
On June 25, Chiatai Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, and the company’s liraglutide injection was approved to be listed in the market, which is used for controlling blood glucose in adult patients with type 2 diabetes mellitus. This is the ninth new product (including new indications) approved by Chiatai Tianqing since this year. The approval of this product also marks Chiatai Tianqing’s formal entry into the field of biopharmaceutical glycemic control. Liraglutide is a long-acting analog of glucagon-like peptide-1 (GLP-1) with 97% homology to natural GLP-1, an endogenous enteric insulinotropic hormone that enhances glucose-dependent insulin secretion from pancreatic β-cells. In addition to pancreatic islet cells, GLP-1 receptors are widely present in gastrointestinal, lung, brain, kidney, cardiovascular system and other organs and tissues. Liraglutide prolongs the half-life of GLP-1 on the basis of retaining the physiological action characteristics of GLP-1, and needs to ...
Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable ...
Dive Brief Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales. The company plans to sell the Dexcom G7 CGM at launch, and is looking to offer additional CGM systems from other manufacturers, according to the company. Customers who want to buy a CGM will be routed to virtual care platform Wheel, where clinicians will determine a patient’s eligibility and write a prescription. Pharmacy tech provider HealthDyne will receive and process prescriptions, and consumers can then purchase the CGMs on Best Buy’s website for delivery to their homes. Dive Insight Best Buy has been increasingly active in healthcare as it angles to solidify itself as a valuable partner for hospitals and health plans looking for ways to help consumers manage their health at home. The company has sold medical devices for at-home use for ...
The FDA has finally approved to market the implantable continuous glucose monitoring system named Eversense, from Senseonics, in the United States.
Medtronic, a medical technology company, and AI-powered personalized nutrition platform Nutrino, have entered into a partnership. The FoodPrint Report technology of Nutrino is slated to be integrated into the iPro2myLog app of Medtronic, a platform which offers continuous glucose monitor enabling users to gain critical insights into their glucose levels.
The company announced that the innovative product, whose technological details are not known yet, is undergoing clinical trials in five cities across the world. The patent-pending invention is based on open standards software and cloud-based analytics. The system gives users real-time notifications and cloud-based AI solutions.
Researchers from the University of California San Diego have developed a low-cost, single-use tattoo-like wearable that measures the user’s glucose levels. According to a release from the institution, this noninvasive technology will be at the center of a newly announced pilot clinical trial designed to test the accuracy and acceptability of the tattoos.
AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorisation Variation forForxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).
Senseonics Holdings Inc has announced that people with diabetes using the Eversense® brand Continuous Glucose Monitoring Systems, in EMEA markets now have the option to invite others to remotely view their real-time glucose readings and alerts from anywhere.
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