Posts by Alyssa Harrison
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…
Read MoreFDA 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…
Read MoreSparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope
Sparrow BioAcoustics recently unveiled its StethophoneTM software, which transforms smartphones into medical-grade stethoscopes. This innovative tool enables users to capture, analyze, and share crucial heart health data with medical professionals from any location. In June 2023, Sparrow received FDA clearance for the downloadable application, making it the first FDA-cleared smartphone stethoscope software-as-a-medical-device (SaMD). The company…
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