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.
Diagnosis & Disease Information
Novel GBCAs Elucirem, Vueway Now Available for Use in Contrast Enhanced MRI
Gadopiclenol only requires half of the gadolinium dose of conventional nonspecific GBCAs.
FDA Approves Xenoview for Evaluating Lung Ventilation
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, a New Macrocyclic Gadolinium-Based Contrast Agent, Gets FDA Approval
Gadopiclenol carries a Boxed Warning associated with an increased risk of nephrogenic systemic fibrosis among patients with impaired elimination of the drugs.
Iomeron Allowed for Temporary Importation to Address Contrast Media Shortage
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.
Fresenius Kabi Launches Generic Iodinated Contrast Media Agent to Alleviate Shortage
Due to COVID-19 related supply-chain disruptions, Iodixanol and other contrast media agents have been in shortage nationwide.
Bludigo Approved as Diagnostic Dye for Cystoscopic Assessment of Ureters
The approval was based on data from a phase 3 study that included 118 adults undergoing endoscopic urological or gynecological surgical procedures.
FDA Authorizes Direct-to-Consumer Test to Detect COVID-19, Influenza, and RSV
The test is the first non-prescription multi-analyte COVID-19 test that allows individuals to test nasal swab samples self-collected at home.
COVID-19 Breathalyzer Test Gets Emergency Use Authorization
The test is performed by exhaling into a tube that is connected to the test kit.
NephroScan Approved to Detect Renal Parenchymal Disorders
NephroScan is a sterile, single-dose kit for the preparation of technetium Tc 99m succimer injection for intravenous use.
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