The Overa® test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The Overa® test is intended to aid in assessing whether a woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy as part of the preoperative evaluation. The Overa® test must be interpreted in conjunction with an independent clinical and imaging evaluation. The test is not intended as a screening or stand-alone diagnostic assay.
An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.
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