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.
Diagnosis & Disease Information
Cytalux Approval Expanded to Include Lung Cancer Detection During Surgery
The approval was based on data from the phase 3 ELUCIDATE study.
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.
FDA Grants Temporary Import of Contrast Media Agent to Address 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.
GE Healthcare Contrast Media Products in Short Supply
Visipaque and Omnipaque are radiographic contrast agents.
Hypersensitivity Reactions to Gadolinium-Based Contrast Agents Studied
History of HSR to iodinated contrast media linked to increased risk for HSR to gadolinium-based contrast agent
FDA: Monitor Young Children for Thyroid Dysfunction After Exposure to Iodinated Contrast Media
The FDA has approved a new warning to the prescribing information for the entire class of ICM injections describing the risk of underactive thyroid or a temporary decrease in thyroid hormone levels.
Lymphoseek Approval Expanded to Pediatric Patients
The approval was based on data from a phase 2 trial that assessed Lymphoseek in pediatric patients with melanoma, RMS, or other solid tumors.
Pafolacianine Sodium Gets Priority Review for Ovarian Cancer Detection During Surgery
Pafolacianine sodium binds to folate receptors commonly found on many cancers, including ovarian and lung cancers, and illuminates the cancerous lesions under near-infrared light.
