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FDA authorizes first dual glucose-ketone monitor for children as young as 2

Published

25 August 2026

Topic

opportunities

Sectors

Medtech

Geography

United States

Source

Read at contemporarypediatrics.com

Verified

Fusion42 · 25 August 2026 · Fusion42 review

The FDA authorized Abbott's Libre Duo 10 Day, the first wearable device to continuously monitor both glucose and ketone levels in patients aged 2 and older with diabetes, through the De Novo premarket pathway.

This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 25 Aug 2026 and 26 Aug 2026.

◆ The Wire takeaway

You can now offer continuous ketone monitoring to young diabetes patients, a clinical gap that routine glucose tracking misses. Abbott’s device opens a new route for early intervention services and product integration in paediatric diabetes care.

Coverage

2 sources · first reported 25 Aug 2026 · latest 26 Aug 2026

Related on Wire

Topics

Medtechfda-approvaldiabetes-monitoringdual-sensorpediatric-healthwearable-device