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FDA Warns Against Using Unauthorized Smartwatches and...

The FDA has not authorized, cleared, or approved any smartwatch or smart ring

21 February 2024

The U.S. Food and Drug Administration (FDA) has issued a safety communication advising against the use of smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin. This warning...

Adapting FDA Regulation for AI and ML in Medical Devices

A Proposed Framework for Safety and Innovation

13 November 2023

The FDA is exploring how to regulate medical devices that incorporate artificial intelligence (AI) and machine learning (ML), acknowledging that their traditional regulatory framework is not fully equipped for the...

Questions you should ask when getting medical device...

An article by Julie Charnet in Wired

7 August 2022

The Food and Drug Administration (FDA) in the US is in charge of ensuring the security of implantable medical devices. There are about thousands of different kinds of devices available, ranging from pacemakers to...

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FDA Warns Against Using Unauthorized Smartwatches and...

The FDA has not authorized, cleared, or approved any smartwatch or smart ring

Adapting FDA Regulation for AI and ML in Medical Devices

A Proposed Framework for Safety and Innovation

Questions you should ask when getting medical device...

An article by Julie Charnet in Wired

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