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.
A team of South Korean researchers is the latest to tout a smart, glucose-sensing contact lens. In a research article published today in Science Advances, the team described soft lenses carrying a tiny LED light that automatically turns off in the event of high glucose levels, as well as their efforts to test the lens in vivo.
Fitbit has invested $6 million in a glucose-monitoring startup called Sano, in what appears to be part of Fitbit’s larger plans to make its fitness devices more valuable for overall health.
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