FDA Approval for ‘Coaching’ Device

A newly FDA-approved mobile diabetes monitor will be the first to deliver real-time clinical feedback based on the user’s input.

The DiabetesManager from Baltimore-based WellDoc, which won Food and Drug Administration marketing clearance on Tuesday, records and analyzes blood glucose data and other diabetes information, then responds with relevant educational and behavioral “coaching.”

Though dozens other devices and online services help to monitor diabetes, DiabetesManager is the only one to have secured FDA approval, a WellDoc spokeswoman tells CNET News. The others others merely record and store data, she said.

DiabetesManager will be marketed to health-care providers and their adult type-2 patients. WellDoc said in a press release it expects to start selling the device early next year.

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