FDA Approves First App-Based Pacemaker Monitor

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Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable pacemakers.

According to Medtronic, the MyCareLink Smart Monitor includes a handheld portable device reader paired with a MyCareLink Smart mobile app on a smartphone or tablet.  The portable device reader receives pacemaker data (when placed in close proximity to the implanted device), and communicates with the mobile app on a smartphone.  The data can then be transmitted to the patient’s physician or clinic (e.g., through cellular or Wi-Fi service).  The MyCareLink Smart Monitor also allows patients to create personal profiles on the MyCareLink Connect Website and receive reminders, confirmations, and notifications about their data transmissions.  HIT Consultant reports that the MyCareLink Smart Monitor will allow for faster treatment, reduced time in clinical care facilities, and potential improvements in survival rates.

Regarding the approval, Darrell Johnson, Vice President and General Manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic stated:

“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.”

Brian Flynn
Brian Flynn focuses on patent preparation and litigation. He counsels clients in a wide variety of technologies, including: · Medical Device: medical and dental instruments, implants, diagnostic equipment, and communication and data systems · Mechanical: automotive technology, sporting goods, kitchen appliances, beverage containers, and toys · Electronics: digital camera technology, mobile devices, GPS devices, and sensor technology Brian received his law degree from the University of Illinois College of Law, where he served as the Secretary for the Intellectual Property Legal Society and as an Articles Editor for the Journal of Law, Technology & Policy. Prior to his legal education, he received a Bachelor's Degree in Bioengineering from the University of Illinois.
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