HealthLeaders Media February 22, 2024
The agency is warning that no devices have been approved that can accurately measure a user’s blood glucose without piercing the skin
KEY TAKEAWAYS
– Some 38.4 million Americans live with diabetes and measure their blood glucose levels every day.
– While digital health companies have made care management easier, they haven’t yet developed a device that can accurately measure blood glucose without piercing the skin.
– The FDA is warning that some devices on the market may be making that claim, which puts users in danger of serious health issues, including death, if they rely on those readings.
Federal regulators are hitting the pause button on digital health advancements for diabetes care management.
The U.S. Food and Drug Administration...
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