FDA Warns Consumers Not to Use Smart Watches or Rings That Claim to Measure Blood Glucose Levels

Wednesday February 21, 2024 12:44 pm PST by Juli Clover The United States Food and Drug Administration (FDA) does not want consumers to purchase or use smart watches or smart rings that claim to measure blood glucose levels using non-invasive methods. In a safety warning shared today, the FDA says that smart devices that claim […]

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Samsung gets FDA approval for sleep apnea feature on Galaxy Watch

Samsung just received approval from the US Food and Drug Administration (FDA) for the sleep apnea feature in the Samsung Health Monitor app. This will detect signs of sleep apnea when using a compatible Galaxy Watch and Samsung phone combo in the US. Which Galaxy Watch, you’re wondering? It’s still unclear, Samsung’s press release doesn’t […]

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Samsung's sleep apnea feature just got FDA approval – will launch later this year

Samsung has announced that its sleep apnea detection feature has been approved for use by the US Food & Drug Administration – a vital step in the company’s quest to solidify the Galaxy Watch a serious health tracker. The feature was first revealed back in October, with Samsung receiving approval from the Korean Ministry of […]

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Samsung's sleep apnea feature just got FDA approval – will launch later this year

Samsung has announced that its sleep apnea detection feature has been approved for use by the US Food & Drug Administration – a vital step in the company’s quest to solidify the Galaxy Watch a serious health tracker. The feature was first revealed back in October, with Samsung receiving approval from the Korean Ministry of […]

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A Cutting-Edge Cancer Treatment Is Under FDA Investigation—for Cancer Risk

Scientists use harmless viruses to ferry and insert the new genetic material because of their natural ability to get inside cells. But the potential for these viruses to accidentally trigger another cancer has long been considered a theoretical risk. In its notice, the FDA said the use of these viruses may have played a role […]

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A Cutting-Edge Cancer Treatment May Cause Cancer. The FDA Is Investigating

Scientists use harmless viruses to ferry and insert the new genetic material because of their natural ability to get inside cells. But the potential for these viruses to accidentally trigger another cancer has long been considered a theoretical risk. In its notice, the FDA said the use of these viruses may have played a role […]

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The FDA Approves Weight Loss Drug Zepbound, a Wegovy and Ozempic Rival

The blockbuster weight loss drug Wegovy has a new rival. Today, the US Food and Drug Administration approved a new drug for weight management called Zepbound, made by American pharmaceutical company Eli Lilly. The weekly injectable drug is meant for adults who are overweight or obese and have at least one weight-related condition, such as […]

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Samsung Galaxy Watch6 will launch with FDA cleared irregular heart rhythm notifications

Today Samsung announced that its irregular heart rhythm notification (IHRN) feature has been cleared by the US FDA. IHRN will be added to the ECG function, helping you track abnormal heart rhythms, and, as the name implies, be notified when one occurs. The feature will debut on One UI 5 Watch, Samsung’s own wear OS […]

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Movano begins blood pressure trials – and is preparing the Evie Ring for FDA clearance

Movano has started blood pressure and glucose trials using its radio frequency (RF) sensor, as it looks to bring medical-grade metrics to consumer wearables. A huge theme of our recent 2023-24 predictions round-up was wearables evolving into medical devices in their own right, and beyond the wellness ones we have today. Movano’s strategy epitomizes this […]

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Garmin ECG approved by FDA – and on the way to watches soon

Garmin has received FDA approval for its electrocardiogram feature – and the new functionality could be on its way to existing devices. It’s been no secret that Garmin has been looking to add ECG functionality to its watches, with trials taking place as far back as 2021. Back in early 2022, we also reported that […]

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Abortion Pills May Force States and the FDA Into a Standoff

For medication abortions, sorting out federal preemption will require fresh lawsuits, which are likely to be brought in states already hostile to abortion, and—depending on their outcome—might rise to a Supreme Court that has already negated abortion rights. Legal experts worry that this could lead to findings with wider implications for federalism as a whole. […]

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The FDA May Nix the Word ‘Milk’ From Your Almond Milk Carton

An official high up in the agency essentially agreed with her critique, Bottemiller Evich reports. The agency has “too many programs and not enough resources,” Janet Woodcock, FDA’s principal deputy commissioner, told her, “and the mismatch is profound.” As for the food division, it’s “really important, but it’s very under-resourced.”  And yet the FDA has […]

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Continuous AFib Monitoring Coming to Fitbit Watches Following FDA Approval

Fitbit owner Google this week came a step closer to rivaling the health features of Apple Watch after the FDA approved its new algorithm for continuously monitoring users’ heart rate rhythms. Like Apple Watch, Fitbit devices with a heart-rate monitoring capability include an ECG app that must be manually run by the user to check […]

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Continuous AFib Monitoring Coming to Fitbit Watches Following FDA Approval

Fitbit owner Google this week came a step closer to rivaling the health features of Apple Watch after the FDA approved its new algorithm for continuously monitoring users’ heart rate rhythms. Like Apple Watch, Fitbit devices with a heart-rate monitoring capability include an ECG app that must be manually run by the user to check […]

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​Fitbit’s passive ECG monitoring feature heads to the FDA

Google has submitted a new Fitbit heart monitoring feature to the FDA, which could automatically alert users to problematic heart rate rhythms. Fitbit is one of a handful of wearable tech companies that offers ECG monitoring, and the feature is available on its Charge 5 and Sense devices. That enables wearables to identify atrial fibrillation […]

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Une app de contrôle de pompe à insuline reçoit le feu vert de la FDA

Ce n’est malheureusement pas encore demain la veille que les montres connectées pourront surveiller le niveau de sucre dans le sang. Les capteurs de glycémie non invasifs sont encore en plein développement, et à cela s’ajoute la nécessité de décrocher le feu vert des autorités de la santé pour que ces appareils puissent être considérés […]

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Bellabeat seeks FDA approval for Ivy fitness tracker

Bellabeat has announced that it’s applied its Ivy tracker approved by the FDA as a medical grade device. The Bellabeat Ivy is a fitness tracker for women, designed specifically to monitor female health. It’s uniquely designed as a piece of jewelry, just like Bellabeat’s usual trackers, and looks like any bracelet. The Bellabeat Ivy’s focus […]

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FDA Says Risk of MagSafe Interference With Pacemakers is Low

Earlier this year, three doctors in Michigan found that iPhone 12 models can “potentially inhibit lifesaving therapy in a patient” due to the MagSafe system causing magnetic interference with implantable medical devices, like pacemakers. Following its own testing, the U.S. Food and Drug Administration this week announced that while certain newer cell phones, smart watches, […]

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