FDA authorizes initial two COVID-19 serology tests Kumar Jeetendra | August 2, 2020 Today, the U.S. Food and Drug Administration approved the initial two COVID-19 serology tests which show an estimated amount of antibodies within somebody’s blood. Both tests from Siemens, the ADVIA Centaur COV2G and Attelica COV2G are what are known as”semi-quantitative” evaluations, meaning that they don’t show an exact measurement, but estimate the number of a …
FDA cautions customers about liquor based hand sanitizers bundled in containers Kumar Jeetendra | August 27, 2020 The U.S. Food and Drug Administration (FDA) is warning consumers around alcohol-based hand sanitizers which are being packaged in containers that may seem as food or beverages and might place users at risk of severe harm or death when ingested. The bureau has found that some hand sanitizers are being packaged in beer cans, children’s …
FDA favors first conventional glucagon for injection to treat extreme hypoglycemia Kumar Jeetendra | December 29, 2020 Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packed in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of …
FDA cautions medical services suppliers and clinical lab staff about SARS-CoV-2 viral transformation Kumar Jeetendra | January 10, 2021 The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential effect of viral mutations, including an emerging version from the United Kingdom known as the B.1.1.7 variant, on approved SARS-CoV-2 molecular tests, which false negative results can occur with almost any molecular test …
FDA permits advertising of new remedy just device to lessen wheezing and mild sleep apnea Kumar Jeetendra | February 6, 2021 Now, the U.S. Food and Drug Administration approved marketing of a new prescription only device intended to reduce snoring and moderate obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time helps prevent the tongue from collapsing …
FDA clears new robotically helped surgical gadget for transvaginal hysterectomy Kumar Jeetendra | March 1, 2021 The U.S. Food and Drug Administration has approved marketing of the Hominis Surgical System, a brand new robotically-assisted surgical device (RASD) that can help alleviate transvaginal hysterectomy in some patients. The Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (elimination of one or both fallopian tubes …
FDA issues emergency use approval for T-Detect COVID Test Kumar Jeetendra | March 7, 2021 Now, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for its T-Detect COVID Exam developed by Adaptive Biotechnologies. The T-Detect COVID Evaluation is a next generation sequencing established (NGS) test to assist in identifying people with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2. …
FDA approves first AI based COVID-19 non-diagnostic screening Kumar Jeetendra | March 21, 2021 Now, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic testing apparatus that identifies certain biomarkers that are indicative of some kinds of conditions, such as hypercoagulation (a condition causing blood to clot more readily than normal). The Tiger Tech COVID Plus …
Universal microplastics can become ‘centers’ for antibiotic-resistant bacteria Kumar Jeetendra | March 22, 2021 It is estimated that an average-sized wastewater treatment plant serving approximately 400,000 inhabitants will discharge up to 2,000,000 microplastic particles to the environment every day. Yet, researchers are still learning the ecological and human health impact of these ultra-fine plastic particles, less than 5 millimeters in length, found in everything from makeup, toothpaste and clothes …
Industrial chemical perfluorobutanoic acid less inclined to aggregate in human lungs and kidneys Kumar Jeetendra | September 25, 2021 A 2013 study by Perez et al. discovered a significant accumulation of the chemical used in industrial production, perfluorobutanoic Acid (PFBA) in the human kidneys and lungs. Researchers from the German Federal Institute for Risk Assessment (BfR) examined the results with an even more precise method for quantification. The resultwas that only one sample had …
