Tag: fda

FDA Clears Three Modules of Chest CT

Images can contain key information, highlight abnormalities The U.S. Food and Drug Administration (FDA) has cleared three modules of AI-Rad Companion Chest CT, an intelligent software assistant from Siemens Healthineers that brings artificial intelligence (AI) to computed tomography (CT). Representing the first intelligent assistant…

ACLA: “Deeply Concerned” by FDA Actions

Pharmacogenetic testing has the Association’s attention In response to the U.S. Food and Drug Administration (FDA)’s troubling actions against pharmacogenetic (PGx) testing, the American Clinical Laboratory Association (ACLA) urged the agency to immediately reconsider and reverse its recent decisions in light of the significant…

Now Hear This: FDA Receives Guidance on OTC Hearing Aids

ASHA, others join forces to offer recommendations Four professional hearing care organizations—including the American Speech and Hearing Association—ASHA—are working together to offer advice to the FDA in terms of optimizing OTC hearing aids. Appropriate labeling, adequate consumer provisions, and other points are emphasized in…

Stay Dry!

FDA approves topical treatment for excessive underarm sweating The U.S. Food and Drug Administration (FDA) has approved topical glycopyrronium (Qbrexza, Dermira) for the treatment of adults and children who have primary axillary hyperhidrosis. Qbrexza is a topical anticholinergic cloth applied to the underarms and…

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