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The FDA smacked Louisville, Ky.-based devicemaker Vivorte with a Form 483 over sterilization lapses observed during an inspection conducted from Nov. 15 to 23, 2021. Read More
Ethicon, a Johnson & Johnson medtech company, has lost its appeal of a patent claim it filed against Intuitive Surgical over an endoscopic surgical stapling device. Read More
Seattle, Wash.-based Magnolia Medical Technologies said the FDA is satisfied with the steps it took to correct violations the agency identified in a warning letter to the company last year and has sent a “close-out notification.” Read More
The blood test panel can simultaneously detect six pathogens that are listed by the Centers for Disease Control and Prevention as potential biothreats. Read More
The FDA has issued a Form 483 to Elite Biomedical Solutions citing problems with its complaint records, process and nonconforming product documentation, and validation procedures. Read More