FDA Approves Online Heart-Device Monitoring
Minnesota-based Medtronic Inc. yesterday announced that it has received FDA approval to market an online network that allows data from patients' implanted defibrillators to be sent to doctors' offices, the Minneapolis Star Tribune reports. The approval will allow some 23,000 heart patients with Medtronic's GEM II DR/VR defibrillator to link to CareLink, the company's fee-based patient management network. Dr. George Crossley, director of Nashville Baptist Hospital's electrophysiology department, who worked on the testing of the network, said, "[It] allows us to extend patient care beyond clinic walls. We get the data we need for follow-up when and where we need it." The network will be marketed to cardiology clinics and academic medical centers, which will pay an "as-yet-undetermined" annual fee per patient to the company. David Lothson, a UBS Warburg analyst, said he estimates that the network will serve 150,000 patients and could generate $250 million in revenue per year by 2006 (Fiedler, Minneapolis Star Tribune, 1/3).