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FDA Authorizes Direct-to-Consumer Test to Detect COVID-19, Influenza, and RSV > Diagnostic Agents

Category: Diagnostic Agents

FDA Authorizes Direct-to-Consumer Test to Detect COVID-19, Influenza, and RSV
COVID19 Diagnostic Agents Diagnostic Testing General Infectious Disease Influenza News Respiratory Diseases/Disorders

FDA Authorizes Direct-to-Consumer Test to Detect COVID-19, Influenza, and RSV

Steve Duffy May 17, 2022

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…

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COVID-19 Breathalyzer Test Gets Emergency Use Authorization
COVID19 Diagnostic Agents Diagnostic Testing General Infectious Disease News Viral Infections

COVID-19 Breathalyzer Test Gets Emergency Use Authorization

Steve Duffy April 15, 2022

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…

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NephroScan Approved to Detect Renal Parenchymal Disorders
Diagnostic Agents Diagnostic Testing General Kidney Disease News

NephroScan Approved to Detect Renal Parenchymal Disorders

Steve Duffy February 23, 2022

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…

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FDA Provides List of At-Home OTC COVID-19 Diagnostic Tests
COVID19 Diagnostic Agents General News

FDA Provides List of At-Home OTC COVID-19 Diagnostic Tests

Top-Meds February 23, 2022

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…

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FDA Clears AI Software Lunit INSIGHT MMG to Detect Breast Cancer

Steve Duffy November 19, 2021

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…

FDA Approves Change in Contraindications for Optison
Cardiovascular Disease Diagnostic Agents Diagnostic Testing General News

FDA Approves Change in Contraindications for Optison

MPR October 6, 2021

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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