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Medical Devices / Submissions and Approvals

Medtronic’s iPad-Based Pacemaker Programmer Receives FDA Clearance

May 7, 2019
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The FDA has cleared Medtronic’s CareLink SmartSync system, a pacemaker manager platform that programs and downloads data from cardiac implants using the Apple iPad.

The Bluetooth-capable system comes with a patient connector, telemetry head, base station and pacing system that weighs a little over two pounds when used with the iPad tablet.

The next-generation programmer and pacing system features encrypted data monitoring and is designed to replicate the interface of Medtronic’s similar device, the CareLink 2090.

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