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Medical Devices / Submissions and Approvals

FDA Clears Hygieia’s Insulin Titration App

Feb. 28, 2019
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Hygieia’s d-Nav insulin guidance service, a smartphone app that titrates insulin doses for Type 2 diabetes patients, received 510(k) clearance from the FDA.

The cloud-based app can adjust doses of insulin regardless of a patient’s regimen type. It uses the patient’s blood glucose data, proprietary algorithms and a team of health professionals to prepare the insulin dosage recommendations.

Using the app, patients input glucose event data and then receive recommendations directly through the app, which can link with a glucose meter to gather data.

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