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.

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.

FDA Releases Closer to Zero: An Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies and Young Children

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

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

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System.

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

The FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.

FDA announced it’s investigating medical device reports describing patient infections associated with reprocessing urological endoscopes used to view and access the urinary tract.

FDA Continues to Advance Over-the Counter and Other Screening Test Development.

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

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.

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.

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

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.

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.

FDA approves drug to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older.

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

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.

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).