St. Jude gets FDA clearance for enhanced internet-based device repository

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The FDA has approved St. Jude Medical’s next-generation Patient Care Network (PCN), an internet-based central repository for patient device data gathered at the time of implant procedures, at in-clinic follow-up visits or from patient-initiated remote follow-up appointments.

The PCN Version 3.0 includes an automated interactive voice response feature, DirectCall Message, which clinics can use to make routine telephone calls to patients, according to the St. Paul, Minn.-based company.

The company said its DirectCall Message automated system can call patients to remind them of upcoming remote follow-up appointments, or to notify them if they miss a remote follow-up appointment. DirectCall Message also can be used to ask patients to call the clinic, or to inform patients that their remote transmissions have been reviewed by the clinic and the results look normal. DirectCall Message does not replace office visits or reduce contact with physicians. However, St. Jude said it is expected to reduce the number of routine calls usually made by clinic staff, while making sure that patients receive important reminders and notifications.