CardioComm seeks FDA clearance for Guava II ECG viewer
CardioComm Solutions has submitted an application with the FDA for clearance of its Guava II ECG viewer technology, medical software device with a formal application programming interface (API). As an API, it can be incorporated and invoked from host applications to provide services for capturing, storing, retrieving, viewing, editing, and analysing electrocardiograms (ECGs). It may be licensed to third party organisations and other software developers interested in embedding the capabilities within their own products.
Guava II will be released as a standalone, class II medical device tool that claims advantages over the current version. It will provide automated ECG triaging capabilities that are relevant for high volume wireless ECG transmissions, and will specifically target the mobile (GMS) cardiac telemetry market in the US. The incorporation of two automated algorithms will enable triaging capabilities that will streamline work flow, reduce staffing costs especially for high volume ECG call centres, and improve the efficiency of identifying potentially life-threatening arrhythmias in monitored patients.
The device will analyse and produce measurements of the ECG recording, as well as textual interpretations. The product will also include an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat-by-beat basis for QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to 12 leads of captured data. Guava II is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and the data acquired from a variety of ECG sources including single- and multi-lead ECG devices.
Once CardioComm receives FDA market clearance for Guava II, this software application will then serve as a platform for future 510(k) submissions as the company introduces new biosignal analyses which, in turn, will support its expanding product portfolio and marketing plans for 2013.