The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, along with other partners, are investigating possible Salmonella contamination of a whey ingredient that has caused the recall of several popular foods. Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder due…
FDA Permits Marketing of Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems
AI Device Uncovers Diabetes-Related Eye Issues
The U.S. Food and Drug Administration is permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina,…
FDA Approves Digital Pill
The U.S. Food and Drug Administration has approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and…
FDA Approves Test That IDs Bloodsteam-Infecting Organisms
The U.S. Food and Drug Administration has allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to (antibiotic sensitivity). The test also reduces the amount of time it…
Unsanitary Milk Products, Valued at $4M, Seized by Feds
The U.S. Food and Drug Administration has announced that the U.S. Marshals Service have seized more than 4 million pounds of product produced by Valley Milk Products LLC (Valley Milk) of Strasburg, Va. The company is owned by the Maryland and Virginia Milk Producers Cooperative Association Inc. in Reston, Va. The seized products include dry…
FDA Questions Efficacy of Hand Sanitizer, Wipe Ingredients
The U.S. Food and Drug Administration has issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these…