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.
Diagnostic Agents
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.
FDA Provides List of At-Home OTC COVID-19 Diagnostic Tests
A list of FDA authorized COVID-19 home tests.
FDA Clears AI Software Lunit INSIGHT MMG to Detect Breast Cancer
Lunit INSIGHT MMG is a deep learning based software that assists radiologists in analyzing mammograms.
FDA Approves Change in Contraindications for Optison
The removal of the contraindication to screen for hypersensitivity to blood and blood products is expected to improve workflow efficiency for health care professionals.
Risk of Falsely Low Results Prompts Recall of Lead Tests
The FDA is concerned that obtaining falsely low test results may lead to inappropriate follow-up assessments, which may result in patient harm.
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