Health news
The Food and Drug Administration (FDA) has authorized for emergency use the Labcorp Seasonal Respiratory Virus RT-PCR direct-to-consumer (DTC) Test for use without a prescription by individuals 2 years of age and older with symptoms…
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the InspectIR COVID-19 Breathalyzer, the first COVID-19 diagnostic test to detect SARS-CoV-2 infection through breath samples. The InspectIR COVID-19 Breathalyzer is…
The Food and Drug Administration (FDA) has approved NephroScan (kit for the preparation of technetium Tc 99m succimer injection) for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adults and…
A list of authorized at-home OTC COVID-19 diagnostic tests is now available on the Food and Drug Administration (FDA) website. These tests, which have all been issued Emergency Use Authorization by the Agency, include: 10-Minute…
The Food and Drug Administration (FDA) has granted 510(k) clearance for Lunit’s artificial intelligence (AI) software, Lunit INSIGHT MMG, for breast cancer detection. Lunit INSIGHT MMG is a deep learning based software that assists radiologists…
The Food and Drug Administration (FDA) has approved updated labeling for Optison (perflutren protein-type A microspheres injectable suspension, USP) that removes hypersensitivity to blood and blood products from the Contraindications section. Optison is an ultrasound…
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