Medtronic's SmartSync iPad Programmer Receives FDA Approval

Samara Rosenfeld
MAY 03, 2019
Medtronic
Photos have been modified. Courtesy of Medtronic.

Medical device maker Medtronic has earned approval for its CareLink SmartSync Device Manager from the U.S. Food and Drug Administration (FDA), according to an announcement.
 
The approval enables physicians to use an Apple iPad to program and manage data from Medtronic’s BlueSync-enabled implanted cardiac devices.
 
SmartSync is a programmer and pacing system analyzer with Bluetooth capabilities, which allow it to communicate with compatible cardiac devices. SmartSync also includes the CareLink SmartSync mobile application, patient connector and base station. Medtronic said the portable technology should help physicians, who are charged with programming and managing cardiac devices and data, to engage with patients.
 
“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 at the Cardiac Rhythm and Heart Failure division of the Cardiac and Vascular Group at Medtronic.
 
Klaus Witte, M.D., lead clinician for cardiology at the University of Leeds in the United Kingdom, said the wireless capabilities and data transfer options of SmartSync increased his efficiency in the lab and gave him more time to interact with patients.
 
Medtronic also built security controls into SmartSync, including multi-encryption, run time application monitoring for intrusion detection and access restrictions to protect the device and data transmissions.
 
SmartSync joins Medtronic’s suite of cardiac care management platforms.

The FDA has been focused on advancing medical devices and streamlining the approval process for technologies that can improve patient outcomes.

The agency overhauled its 510(k) pathway to advance new technologies and is working with the Centers for Medicare and Medicaid Services to increase access to novel devices and provide coverage opportunities for Medicare beneficiaries.

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