FDA clears St. Jude's updated patient care network

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The FDA has approved St. Jude Medical's newest version of the Merlin.net Patient Care Network (PCN), an internet-based remote care system for patients with implanted medical devices.

The remote care system gathers and stores data from the implant procedure, in clinic follow-up visits or from both patient-initiated and automatic remote follow-up and monitoring transmissions, the St. Paul, Minn.-based company said. The updated Merlin.net PCN Version 3.1 expands on features designed to improve access to information to help them manage their patients' devices. With its open architecture and standards-based interface, Merlin.net PCN also is integratable with standard EHR systems.

St. Jude said that its latest version of Merlin.net PCN adds new options to its DirectAlerts Notification feature, which can be used to alert a physician - including an on-call physician outside normal business hours - to changes in the device or the patient's disease state.

The DirectAlerts Notification feature allows the physician to monitor patients for changes in certain diagnostic criteria, such as atrial fibrillation, between scheduled follow-ups. The changes trigger the device to store the data, send it to Merlin.net PCN and notify the physician it is available for review.

The DirectCall Message feature provides pre-recorded messages that clinics can program to call patients to remind them of an up-coming scheduled follow-up transmissions, notify them if they have missed a scheduled follow-up transmission, inform them that their remote transmission has been received, according to the company.