Food and Drug Administration

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FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis Patients

Ven, 26/03/2021 - 17:30
FDA has authorized marketing of a new device intended for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis.
Categorie: Istituzioni

FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease

Ven, 26/03/2021 - 16:50
Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract, the part of the heart that carries blood out of the right ventricle to the lungs.
Categorie: Istituzioni

FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients

Gio, 25/03/2021 - 23:03
FDA approves drug to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: March 23, 2021

Mar, 23/03/2021 - 22:32
Coronavirus (COVID-19) Update: March 23, 2021
Categorie: Istituzioni

FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief

Lun, 22/03/2021 - 18:55
Today, the U.S. Food and Drug Administration issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection

Ven, 19/03/2021 - 23:44
Today, the FDA authorized the first machine learning-based COVID-19 screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal).
Categorie: Istituzioni

Coronavirus (COVID-19) Update: March 19, 2021

Ven, 19/03/2021 - 20:08
Coronavirus (COVID-19) Update: March 19, 2021
Categorie: Istituzioni

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process

Mer, 17/03/2021 - 22:50
The FDA grants marketing status to BioFire Diagnostics LLC for its BioFire Respiratory Panel 2.1. This is the first SARS-CoV-2 diagnostic test that the FDA has granted full marketing status to in the U.S. since the start of the public health emergency.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: March 16, 2021

Mar, 16/03/2021 - 21:53
Coronavirus (COVID-19) Update: March 16, 2021
Categorie: Istituzioni