FDA Clears Single-Use PCR Test That Rapidly Detects STIs in Women
The test aids in the diagnosis of symptomatic or asymptomatic infections with C. trachomatis, N. gonorrhoeae, and T. vaginalis.
The test aids in the diagnosis of symptomatic or asymptomatic infections with C. trachomatis, N. gonorrhoeae, and T. vaginalis.
Gadopiclenol only requires half of the gadolinium dose of conventional nonspecific GBCAs.
The approval was based on data from 2 clinical trials that compared Xenoview MRI to xenon Xe 133 scintigraphy in adults with pulmonary disorders.
Gadopiclenol carries a Boxed Warning associated with an increased risk of nephrogenic systemic fibrosis among patients with impaired elimination of the drugs.
To address the ongoing COVID-19 related iodinated contrast media product shortage, Iomeron will be temporarily available in the US starting at the end of August 2022.
Due to COVID-19 related supply-chain disruptions, Iodixanol and other contrast media agents have been in shortage nationwide.
The approval was based on data from a phase 3 study that included 118 adults undergoing endoscopic urological or gynecological surgical procedures.
The test is the first non-prescription multi-analyte COVID-19 test that allows individuals to test nasal swab samples self-collected at home.
The test is performed by exhaling into a tube that is connected to the test kit.
NephroScan is a sterile, single-dose kit for the preparation of technetium Tc 99m succimer injection for intravenous use.