FDA Approves Medtronic Cardiac Device Manager for iPad Use

MAY 02, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved Medtronic’s CareLink SmartSync Device Manager to help physicians manage and program data from the company’s BlueSync-enabled implanted cardiac devices with an Apple iPad.

The new device manager will provide users with a simplified interface, Bluetooth capability, and a portable device that weighs about 2 lbs. The SmartSync includes a mobile application, telemetry head, and pacing system analyzer that allows for direct patient-to-physician data sharing.

In January, Ireland-based medical device company Medtronic launched the MyCareLink Heart mobile app, which allows patients to use smart, Bluetooth-capable technology to communicate with compatible cardiac devices, including a series of marketed quadripolar cardiac resynchronization therapy pacemakers.

Having been approved in 20-plus countries, SmartSync Device Manager will be fully launched in the US markets this August. Klaus White, MD, associate professor and consultant cardiologist, and lead clinician for cardiology at the University of Leeds, said the wireless capabilities and data transfer options of the device will help physicians improve their laboratory efficacy, and potentially allow for them to interact more with patients and colleagues—as it had for him.

"This type of portable device programing represents the future of cardiac data technology," White said in a statement.

In an interview with MD Magazine®, Larry Chinitz, MD, director of Cardiac Electrophysiology and clinical director of Cardiology at NYU Langone Health, praised the transformation of care delivered by wearable devices and subcutaneous monitors—but cautioned that healthcare providers will see a greater brunt of work because of it.



“I think the advent of artificial intelligence now into some of these devices, to really look more deeply into making diagnoses and making people aware with greater accuracy—much of the problems that we have in our clinic is we manage thousands of patients remotely with pacemakers, defibrillators, subcutaneous monitors,” he explained. “The data comes in, and sometimes it's hard to figure out. It's not always so clear what we are seeing, and we need really improvements in that.”

As a transitive platform from the physician-familiar CareLink 2090 interface, SmartSync seeks to only simplify the cardiac specialist’s telehealth monitoring, Rob Kowal, MD, PhD, said.

"Medtronic is committed to developing smart technology solutions that help physicians seamlessly provide high-quality care to cardiac patients," said Kowal, 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.”

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