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Medical Devices / Submissions and Approvals

Medtronic Scores FDA Approval for Remote Patient Monitoring Pacemakers

Nov. 27, 2017

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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