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FDA Authorizes First Wearable Device to Continuously Monitor Glucose, Ketones
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Fusion42 · 25 August 2026 · Fusion42 review
The FDA has authorised the first wearable device capable of continuously monitoring both glucose and ketone levels, marking a regulatory milestone in diabetes and metabolic health management.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
Medtech founders focused on metabolic monitoring face a new FDA clearance pathway; the bar is set for integrated continuous sensing devices that combine glucose and ketones. You need to act fast to adapt product roadmaps or risk losing ground to this standard-setting wearable.
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1 source · 25 Aug 2026
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