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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
The EU’s Medical Device Coordination Group (MDCG) clarifies in a new guidance that seemingly minor changes can make it necessary for a device manufacturer to assign a new UDI-DI to a product. Read More
The company also reported that another of its rapid COVID-19 antigen assays, the LumiraDx SARS-CoV-2 Ag Test, has received an Emergency Use Listing from the World Health Organization. Read More