FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor

On March 5, the U.S. Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. Following this announcement, Dexcom’s shares experienced a 2.2% increase in extended trading. Known as Stelo, this device is tailored for individuals aged 18 and older who do…

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FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis

Boston Scientific’s AGENT™ Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. While advancements in percutaneous coronary intervention (PCI) technologies are ongoing, recent research indicates that ISR, the gradual re-narrowing of a previously opened coronary artery, still…

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