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Medical Devices / Submissions and Approvals

Medtronic Scores FDA Approval for Remote Patient Monitoring Pacemakers

Nov. 27, 2017
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Medical device manufacturing giant Medtronic has received FDA approval for its Azure pacemaker portfolio, which includes the Azure XT MRI and Azure S MRI.

The pacemakers allow for automatic, wireless remote monitoring, using Medtronic-exclusive BlueSync technology, for a care provider’s evaluation of the patient’s time sheets.

The company said it implemented security controls on the BlueSync technology, such as access restrictions to ensure device integrity and end-to-end encryption to protect patients’ health data.

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