FDA approves first app-based monitoring system for pacemakers

Medtronic announces FDA approval and the launch of World's first app-based remote monitoring system for pacemakers

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The MyCareLink Smart Monitor is comprised of a handheld portable device reader and the MyCareLink Smart mobile app

Medtronic has announced the US Food and Drug Administration (US FDA) approval and the US commercial availability of the MyCareLink Smart Monitor, the world's first app-based remote monitoring system for patients with implantable pacemakers. With the MyCareLink Smart Monitor, patients with a Medtronic pacemaker can 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.

The MyCareLink Smart Monitor is comprised of a handheld portable device reader, prescribed by a physician, and the MyCareLink Smart mobile app, available for free 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, the world's leading remote monitoring service for cardiac device patients, currently being used by more than one million patients.

In addition to sending information from their pacemakers to their physicians or clinics, patients using the MyCareLink Smart Monitor can 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.

By connecting patients and physicians, remote cardiac monitoring provides many clinical and economic benefits. These include faster time to treatment if the physician detects a problem with the pacemaker based on the transmitted data; less time spent at a doctor's office or clinic for regular checks of the pacemaker reduced time spent in the hospital if the physician quickly detects and treats a medical problem and a potential increase in patient survival rates.

"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," said Mr Darrell Johnson, vice president and general manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic. "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. The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement."

 

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