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.