Care Link

Medtronic Receives FDA Approval for CareLink SmartSync Device Manager

Posted on May 07, 2019 by Medtech[y] Staff


Medtronic announced they have received FDA approval for their CareLink SmartSync Device Manager, giving physicians the ability to use an Apple iPad to program and manager data from Medtronic's BlueSync-enabled implanted cardiac devices. The SmartSync Device Manager received CE Mark approval in 2018 and is available in select U.S. sites with a full U.S. launch expected in August 2019.

"Medtronic is committed to developing smart technology solutions that help physicians seamlessly provide high-quality care to cardiac patients," said Rob Kowal, M.D., Ph.D., chief medical officer, vice president of medical affairs and business development of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. "SmartSync is another important innovation reinforcing that commitment. Clinicians will benefit from the portability that SmartSync offers, and because it was built to replicate the familiar CareLink 2090 interface, the transition to this new technology is quite simple."

In January 2019, Medtronic launched the MyCareLink Heart mobile app, which allows patients to use bluetooth enabled smart technology to communicate with compatible BlueSync-enabled pacemakers, including the Azure and Percepta pacemakers, and Serena and Solara quadripolar cardiac resynchronization therapy pacemakers (CRT-Ps). Additionally, Medtronic recently launched MyCareLink Heart, allowing patients to monitor their pacemakers through a smartphone app.

As Medtronic has recently faced security issues, the company developed the SmartSync system to ensure all connected devices feature "multi-encryption, run time application monitoring for intrusion detection, and access restrictions designed to protect the device and data transmissions."

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