FDA Approves Pacemaker with Transmitter
The FDA yesterday approved a pacemaker "outfitted with a tiny transmitter" that allows doctors to monitor a patient's heart from a different room -- the "first medical implant capable of such real-time monitoring," the AP/Baltimore Sun reports. The transmitter in the Biotronik Home Monitoring System, manufactured by Biotronik Inc., "automatically" sends data on a patient's heart to a "cell-phone like device the patient keeps nearby." The device "makes a cellular call that downloads the data wirelessly and faxes the medical records straight" to a physician's office. As a result, doctors can monitor the condition of a patient's heart "weekly or even" daily, rather than only during scheduled appointments. In addition, when a doctor detects a problem, he can "urge the patient to come in for treatment before the problem worsens." Patients must place the cell-phone like device within 6 feet of the body to receive signals from the transmitter. Biotronik "suggests" that patients should place the device near their bed and that doctors should transmit data at 2 a.m. daily.
Biotronik plans to limit sales of the monitoring system to 100 patients at 10 medical centers during the "first few months" to determine "how well it will work in real life." According to Mark Johnson, Biotronik's manager of the system, the company will sell the device for about $5,000, "comparable to standard pacemakers." Dr. Timothy Gardner, a spokesperson for the American Heart Association, said that the Biotronik system represents a "first step" toward allowing doctors to conduct "remote health monitoring" of patients on a regular basis. "The next steps of getting actual full physiological monitoring may be more difficult, but I'm sure we'll reach a point where that kind of information being transmitted to a doctor's office will be just like the telemetry we do on patients when they're in the hospital," he said (AP/Baltimore Sun, 10/12).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.