Tag: FDA approval

  • FDA Approves First OTC Glucose Monitor Dexcom Stelo System – Smartphone Pairing

    FDA Approves First OTC Glucose Monitor Dexcom Stelo System – Smartphone Pairing

    A significant advancement in diabetes management was achieved on March 6th following the FDA's approval of Dexcom's Stelo glucose biosensor system. This innovative technology, a pioneering creation, permits non-insulin-dependent diabetes individuals or those prone to the condition to conduct blood sugar monitoring without the need for a prescription.

    Revolutionary Glucose Monitoring System

    The Stelo system diverges from traditional methods by employing a wearable sensor and a smartphone application to provide continuous glucose level monitoring, showcasing readings every quarter of an hour. Each sensor boasts a lifespan of up to 15 days before necessitating replacement, offering a durable and user-friendly solution.

    FDA's Acknowledgment of Significance

    The FDA underscored the importance of this approval, accentuating its capability to enhance the accessibility of blood sugar monitoring and enable individuals to oversee their health conveniently within their residences.

    Striving Towards Non-Invasive Monitoring

    While Stelo signifies a notable advancement, the ultimate aim in diabetes management remains non-invasive blood glucose monitoring. Although this technology was initially intended for the Apple Watch, current constraints have hindered its realization. Additionally, the FDA warns against unapproved non-invasive alternatives, pointing out their lack of reliability.

    Despite the absence of non-invasive choices presently, Dexcom's Stelo stands as a substantial leap in diabetes management, providing a practical and attainable option for numerous individuals. The future of blood sugar monitoring holds the potential for further innovative and non-invasive methodologies.

    Tags: , ,
  • FDA Approves Samsung Galaxy Watch for Sleep Apnea Detection

    FDA Approves Samsung Galaxy Watch for Sleep Apnea Detection

    Samsung has received FDA approval to introduce a sleep apnea detection feature for Galaxy Watch users in the United States. This makes Samsung the first smartwatch maker to gain such approval by the FDA. The company, however, already got approval for this feature in South Korea back in October 2023.

    Monitoring Sleep Apnea with Galaxy Watch

    Sleep apnea is a chronic condition that prevents a person from breathing while asleep. This can lead to reduced sleep quality and an increased risk of serious health issues like heart disease. It’s incredibly common but often undiagnosed.

    While Samsung remained tight-lipped on the exact method it will use for detection, the Galaxy Watch is equipped with the necessary sensors to monitor factors associated with sleep apnea. For instance, the watch can accurately detect changes in blood oxygen levels and heart rate, which should be pretty useful for the feature to work.

    Collecting Data for Analysis

    Users will need to wear the watch while sleeping for at least two nights within a ten-day timeframe to collect sufficient data for analysis. You can then view the results on the Samsung Health Monitor app. Also, it’s important to note that the feature is only for adults over 22 who haven’t already been diagnosed with sleep apnea.

    Sleep apnea detection is a valuable addition to the Galaxy Watch’s suite of health monitoring features. While not a substitute for formal diagnosis, it could be life-saving by detecting sleep apnea proactively.

    Apple’s Efforts and Availability

    Apple is also said to be working on a sleep apnea detection feature for its smartwatch. However, the company might face obstacles due to ongoing legal restrictions regarding its SpO2 sensor.

    Nonetheless, the feature will be rolled out to Galaxy Watch users in the United States later this year. However, it is likely to be available only on newer models like the Galaxy Watch 5 and 6 series.

    Tags: , ,