Aidoc, a global leader in clinical AI, has secured a defining FDA clearance for a CADt AI solution powered by a foundation ...

VIA360 Surgical System with proprietary ActiveInject Technology delivers viscoelastic where you want it, when you want it, giving surgeons unmatched precision and control. RANCHO CUCAMONGA, CALIFORNIA ...

Hologic (HOLX) announced that the FDA has granted 510(k) clearance for the company’s Aptima SARS-CoV-2 assay, which was first granted Emergency ...

Targeted Genomics LLC, a family owned genetic testing Company, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its Direct-to-Consumer GlutenID test. GlutenID ...

The U.S. Food and Drug Administration has made an update to its MadeGood granola bar recall. The popular granola bars, sold on Amazon and in stores like Target, Whole Foods, Wegmans, CVS, among ...

Thomas Cooper’s parents hoped the oxygen therapy he was receiving at a facility in Troy, Michigan, would help his sleep apnea ...

A groundbreaking study in Nature Medicine reveals that GD2 CAR-T cell therapy can lead to long-term remission in children ...

At that time, no allergic reactions related to recall were reported. On Feb. 13, the FDA classified the recall of the pancake and waffle mix to the highest level, a Class I. The FDA defines a ...

Thomas died on January 31 after what police and fire officials called a ‘fiery explosion’ in the oxygen chamber. Now James ...

Probationary employees across the FDA received notices Saturday evening that their jobs were being eliminated, according to three FDA staffers who spoke to The Associated Press on condition of ...

With no fanfare after 89 reported sick, the FDA has closed its investigation into a romaine lettuce E. coli outbreak without telling the public more and the CDC continues to remain mum.

So, what do terms like “FDA-approved,” “FDA-cleared,” and “FDA-regulated” mean—and why do these labels matter? Understanding the differences will help you cut through the buzzwords ...