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The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, a combination drug/device manufacturing facility in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More
The trial is evaluating the procedure’s ability to grant durable insulin-free glycemic control in patients who aren’t getting adequate control on insulin therapy. Read More
The SleepHub device works by playing scientifically formulated sounds through high- quality speakers, using specific beats and pulses to help modulate sleep patterns and emulate brain waves produced during sleep. Read More
The test runs on the common cobas 6800/8800 Systems and features a pre-optimized assay design, ready-to-use cassettes and pre-defined software parameters. Read More
According to AFYX, the device is the first biodegradable oral adhesive patch designed to locally deliver clobetasol, a corticosteroid used for skin conditions, to treat oral lichen planus lesions. Read More
The test uses technology that can detect a specific spot where mutation occurs, allowing for precise detection and differentiation of the coronavirus from mutated strains. Read More
The U.S. has joined the World Health Organization (WHO)’s Access to COVID-19 Tools (ACT) Accelerator program, a global effort to speed development and production of coronavirus vaccines, treatments and diagnostic tests, and to help lower-income nations obtain them. Read More
The handheld device directs precise wavelengths of targeted light to the back of the throat and surrounding tissues and is designed for at-home treatment of mild-to-moderate COVID-19 in adult patients. Read More