By MacRumors Staff

FDA Articles

watchos 9 afib history

Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

Thursday May 2, 2024 4:27 am PDT by
Apple's atrial fibrillation (AFib) history feature on Apple Watch has been qualified by the FDA under its Medical Device Development Tools (MDDT) program, the first digital health technology feature of its kind to do so. Since 2022, Apple Watch has supported AFib History, which allows users diagnosed with atrial fibrillation to view an estimate of how frequently their heart is in this type...
Apple Watch Blood Glucose Monitoring Feature 2

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

Wednesday February 21, 2024 11:44 am PST by
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 to check blood sugar without piercing the skin can lead to errors in diabetes management, including taking too much or too...

FDA Says Risk of MagSafe Interference With Pacemakers is Low

Friday May 14, 2021 11:11 am PDT by
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, and other...

Apple Joins FDA Pilot Program for Faster Approval of Digital Health Tools

Tuesday September 26, 2017 11:03 am PDT by
The Food and Drug Administration today announced that it has selected nine companies to join its voluntary Pre-Cert pilot program, which is designed to foster innovation through the creation of a less restrictive regulatory framework that will lead to faster acceptance of health-related software and, in some cases, products. Companies accepted to the program include Apple, Fitbit, Johnson &...
apple watch activity blue

FDA Taking 'Almost Hands-Off Approach' to Regulating Apple Watch and Similar Wearables

Monday March 30, 2015 6:21 am PDT by
As Apple and other companies create products capable of providing more and more detailed health-related information, the U.S. Food and Drug Administration has decided to give the companies creating these devices breathing room to manufacture the devices free, for the most part, from the scrutiny of the agency (via Bloomberg Business). The FDA's associate director for digital health, Bakul...