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The FDA has outlined its latest thinking in a draft guidance on how companies should report manufacturing or supply issues that might reduce or eliminate the availability of critical equipment during a public health emergency. Read More
The device removes infected tissue and biofilms, killing up to 99 percent of bacteria commonly found in the root canal, according to the companies. Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice to device manufacturers on how to register their products now that the country no longer relies on the EU’s CE mark. Read More
Stryker is acquiring San Jose, Calif.-based Vocera Communications in a $3 billion purchase that will increase the medical device giant’s digital healthcare portfolio. Read More
Rapid antigen COVID-19 testing in adults doesn’t identify as many early infections as reverse-transcriptase polymerase chain-reaction (RT-PCR), but in children, accuracy was quite high, two new studies have found. Read More
Rhythm Biosciences’ ColoSTAT is an immunoassay, a biochemical test that measures the presence or concentration of multiple protein biomarkers for colorectal cancer. Read More
The breakthrough designation was based on the results of a clinical trial in which the treatment led to improvements in communication and living skills. Read More
If the graphical biopsy depth gauge is no longer synchronized with other navigation views during neurosurgery, it may result in “tissue injury, including potential for life-threatening injury,” the FDA said. Read More