Food and Drug Administration

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FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer

Ven, 09/04/2021 - 23:37
FDA authorized marketing of the GI Genius, the first device that uses artificial intelligence based on machine learning to detect lesions in the colon in real time during a colonoscopy.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 9, 2021

Ven, 09/04/2021 - 20:35
The FDA recommends health care personnel and facilities transition from the use of decontaminated disposable respirators, and issues warning letters to two companies for selling unapproved products with fraudulent COVID-19 claims.
Categorie: Istituzioni

FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children

Gio, 08/04/2021 - 19:28
FDA Releases Closer to Zero: An Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies and Young Children
Categorie: Istituzioni

FDA Releases Investigation Report Following Fall 2020 Outbreak of E. coli O157:H7 Illnesses Linked to Leafy Greens

Mar, 06/04/2021 - 21:34
FDA publishes investigation report into Fall 2020 outbreak of Shiga Toxin-Producing E. coli (STEC) O157:H7 illnesses linked to the consumption of leafy greens
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 6, 2021

Mar, 06/04/2021 - 21:02
Coronavirus (COVID-19) Update: April 6, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

Mar, 06/04/2021 - 17:02
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: April 2, 2021

Ven, 02/04/2021 - 23:46
Coronavirus (COVID-19) Update: April 2, 2021
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available

Ven, 02/04/2021 - 02:24
The FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.
Categorie: Istituzioni

FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes

Gio, 01/04/2021 - 17:40
FDA announced it’s investigating medical device reports describing patient infections associated with reprocessing urological endoscopes used to view and access the urinary tract.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development

Gio, 01/04/2021 - 03:53
FDA Continues to Advance Over-the Counter and Other Screening Test Development.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: March 30, 2021

Mar, 30/03/2021 - 21:12
Coronavirus (COVID-19) Update: March 30, 2021
Categorie: Istituzioni

FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care Settings

Mar, 30/03/2021 - 17:45
FDA announced the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Waiver.
Categorie: Istituzioni

FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma

Sab, 27/03/2021 - 15:43
The FDA approved Abecma, the first cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.
Categorie: Istituzioni

Coronavirus (COVID-19) Update: March 26, 2021

Ven, 26/03/2021 - 21:35
Coronavirus (COVID-19) Update: March 26, 2021
Categorie: Istituzioni

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