Permanently implantable diagnostic computerized devices: where is the regulatory rar?
Krucoff
Mitchell W
MW
eECG Core Laboratory, Duke University Medical Center/Duke Clinical Research Institute, Durham, NC 27705, USA. kruco001@mc.duke.edu
D017147:Defibrillators, Implantable; D018795:Device Approval; D015716:Electrocardiography, Ambulatory / Q000295:instrumentation*; D004567:Electrodes, Implanted; D004867:Equipment Design; D033161:Government Regulation; D006801:Humans; D013677:Medical Laboratory Science / Q000295:instrumentation; D010138:Pacemaker, Artificial; D012307:Risk Factors; D012815:Signal Processing, Computer-Assisted / Q000295:instrumentation*; D012984:Software; D014481:United States