Medtronic’s app-based remote monitoring system for pacemakers clears the FDA hurdle

MyCareLink Smart Monitor

Medtronic has scored an FDA approval for its MyCareLink Smart Monitor, the world’s first app-based remote monitoring system for patients with implantable pacemakers. The company is also announcing the product availability in the U.S. allowing patients with a Medtronic pacemaker to use their own smartphone or tablet to securely transmit data from their pacemakers to their physicians, who can then interpret the data to make treatment decisions.

The MyCareLink Smart Monitor is comprised of a handheld portable device reader and the MyCareLink Smart mobile app.The MyCareLink Smart Monitor is comprised of a handheld portable device reader, prescribed by a physician, and the MyCareLink Smart mobile app, 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, which is currently being used by more than 1 million patients.

Also, patients can use the MyCareLink Smart Monitor to confirm the date of their most recent transmission of pacemaker information, create a personalized profile on the MyCareLink Connect Website to manage their pacemaker information and data transmissions, and receive email or text reminders, confirmations and notifications of their data transmissions.

“As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare,” said Darrell Johnson, vice president and general manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic. “The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement.”