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FDA Warns Against Using Unauthorized Smartwatches and...

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...
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Review and Comparison of Top Continuous Glucose Monitors

Review and Comparison of Top Continuous Glucose Monitors

Wired's In-Depth Analysis

5 December 2023
Continuous Glucose Monitoring (CGM) devices are advanced tools used primarily by individuals with diabetes to continuously track glucose levels in their body. These devices offer a significant advantage over...
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US Blood Pressure Validated Device Listing

US Blood Pressure Validated Device Listing

Blood pressure measurement devices that have been validated for clinical accuracy as determined through an independent review process.

26 November 2023
High blood pressure (BP) that is uncontrolled is the major cause of mortality and disability. For the diagnosis and treatment of hypertension, reliable blood pressure measurement is critical. If the BP measurement...
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Adapting FDA Regulation for AI and ML in Medical Devices

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...
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Finding suggest value in self-management of blood pressure

Finding suggest value in self-management of blood pressure

Better hypertension management by both in-office and at-home blood pressure results

4 May 2023
Blood pressure readings taken in a physician's office can vary due to timing, equipment, and biological factors. Studies have linked variability between visits to an increased risk of cardiovascular disease and...
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