Zdrowie i gospodarka · 24/10/2001

Electronic Interchange Standard for Digital ECG and Similar Data; Public Meeting

The Food and Drug Administration (FDA) is announcing a public meeting to collect information regarding the content and format of electrocardiographic (ECG) data to be submitted to the agency in support of applications. The agency is interested in obtaining ECG waveform data in digital format from the full spectrum of ECG devices (i.e., standard 12-lead ECGs, Holter monitors, transtelephonic monitors, and implanted devices) along with annotations for events (e.g., standard ECG interval measurements, arrhythmic events).