App-based remote monitoring system for pacemakers gains FDA approval

The US Food and Drug Administration (FDA) has approved US commercial availability of the MyCareLink Smart Monitor and app-based remote monitoring system for patients with implantable pacemakers

The MyCareLink Smart Monitor enables patients with a Medtronic pacemaker to use their own smartphone or tablet technology with cellular or Wi-Fi service to securely transmit data from their pacemakers to their physicians who can then interpret the data to make treatment decisions.

George Crossley, associate professor of medicine and electrophysiologist at Vanderbilt Heart and Vascular Institution in Nashville, Tennessee, said: “Because the MyCareLink Smart Monitor is integrated into existing mobile platforms like smartphones and tablets it is easy for patients to transmit data from their pacemakers to their doctors via the technology that they are using every day.

“This innovation will serve as the foundation for future advances using smart technology to support cardiac patients."

The MyCareLink Smart Monitor is comprised of a handheld portable device reader, prescribed by a physician and the MyCareLink Smart mobile app that is available on both Android and Apple platforms.

When the MyCareLink Smart Monitor is connected to cellular or Wi-Fi service, patients can initiate a transmission of pacemaker data by securely uploading the information to the Medtronic CareLink Network.

Darrell Johnson, vice president and general manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic, said: "The use of smart technology continues to grow among people of all ages, and especially among people over 65 which is the age range of the majority of our pacemaker patients.

“The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement."