FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

TGA Signs Off on Glucose Monitor for iPhones

Dec. 26, 2017
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Australia’s Therapeutic Goods Administration has given its TGA Mark for DarioHealth Corp’s Blood Glucose Monitoring System for iPhone use.

The system was previously unapproved for the Lightning connector found in later-model Apple smartphones, according to an announcement from the company.

The approval also ensures that users in the United Kingdom will have access to the Lightning-enabled Dario device at the end of December. Sales of the device in Australia will begin in January, the company said.

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