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Medical Devices / Submissions and Approvals

Voluntis Scores FDA Clearance and CE Mark for Insulia

Dec. 7, 2016

Voluntis has received FDA marketing clearance and the CE Mark for Insulia.

The application software gives patients insulin dose recommendations and coaching messages in response to blood glucose values and other diabetes-related data.

A clinician programs the range in which patients need to be. The dose adjustment calculations are synced into the application and are accessible to the patient via a web portal or by smartphones and tablets.

Insulia will be available in the first half of 2017. — Cynthia Jessup

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