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Tag: U.S. FDA

  1. Apple Watch Series 4 ECG should pave way for more medical gadgets, U.S. FDA says

    The nation’s top medical-device regulator wants to make it easier…

  2. Apple Watch Series 4’s electrocardiogram feature received FDA clearance just one day before ‘Gather Round’ event

    Some on the Apple Watch team may have felt their hearts pounding in the days leading up to…

  3. The Apple Watch is inching toward becoming a medical device

    Apple Watch adds features that allow it to take high-quality heart readings and detect falls…

  4. What the Apple Watch Series 4’s FDA clearance actually means

    Apple announced that the US Food and Drug Administration cleared two new features for the Apple Watch Series 4…

  5. U.S. FDA selects participants, including Apple, for new digital health software precertification pilot program

    Today, the U.S. Food and Drug Administration announced the names of the companies selected to participate…

  6. Apple plans to release a cellular-capable Apple Watch later this year

    Apple Inc. is planning to release a version of its smartwatch later this year…

  7. Apple Watch Series 3 could sport MicroLED display, cellular connectivity, Apple Smartbands

    Apple Watch Series 3 could offer a glass-film touchscreen…

  8. Apple Watch 3 rumor, er… watch

    The Apple Watch Series 3 rumors we’ve heard suggest Cupertino plans on sticking with…

  9. Apple Watch sales could soar with new U.S. FDA plan

    Apple Inc.’s Apple Watch has been what is probably best described as a modest success…

  10. AliveCor has FDA-approved heart tracker for Apple Watch

    AliveCor is building sensors the Apple Watch…

  11. Apple invention turns Apple Watch into a full-fledged medical device

    A patent application published Thursday suggests Apple is working to turn Apple Watch into…

  12. Current Apple Watch may also measure blood oxygen saturation with software update

    Apple Watch features hardware capable of measuring blood oxygen saturation levels…

  13. Apple Watch teardown reveals pulse oximeter, suggesting future measurement of blood oxygen

    iFixit’s teardown of the Apple Watch has revealed that the sophisticated heart-rate monitor…

  14. FDA ‘taking a very light touch’ on regulating the Apple Watch

    With Apple Inc. and fellow Silicon Valley companies edging further into health care…

  15. Apple Watch not ready for full health tracking mode, yet

    When the highly-anticipated Apple Watch finally hits shelves in April…

  16. Apple Watch to support DexCom’s glucose monitor at launch

    Apple Watch gets an early foothold in the health-care market at a time when…

  17. As Apple Watch looms, U.S. FDA clarifies regulatory stance on health-tracking wearables

    The U.S. Food and Drug Administration has issued preliminary guidance…

  18. Cedars-Sinai-backed app for Apple iPad, iPod touch receives U.S. FDA approval

    The FDA clearance is for the whole system: the software, the earbuds, and the Apple devices…

  19. Apple’s new health focus comes at propitious time

    Hospitals are under federal regulatory pressure to improve how they treat patients…

  20. U.S. FDA details high-level meeting with Apple: ‘Moral obligation to do more’ with health, innovative sensors

    Apple believes there is the opportunity to do more with devices…

  21. Wanted: a watchdog for the mobile medical app explosion

    Seventy-five percent of smartphone apps that claim to assess malignancy are wrongly diagnosing..

  22. Will Apple’s HealthBook app draw government regulation?

    With the “Affordable Care Act” suffering from a lack of enrollment…

  23. With Healthbook, Apple will asserts itself as the platform for digital health

    Emerging details about Apple’s forthcoming Healthbook app suggest the tech giant…

  24. Apple’s looming Healthbook app is the start of something huge

    Apple is poised to launch a body-monitoring app known as Healthbook…

  25. Healthbook: Apple’s major first step into health and fitness tracking revealed

    Seven years out from the original iPhone’s introduction…

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