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Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection of its Evanston, Illinois facility. Read More
Failure to submit medical device reports to the FDA within the prescribed timeframe and lax complaint handling landed duodenoscope maker Olympus a Form 483 following an FDA inspection of its San Jose, California facility. Read More
The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests. Read More
The National Institutes of Health has announced a new round of contracts totaling $129.3 million to support new COVID-19 testing technologies. Read More
The European Commission’s Medical Device Coordination Group announced that a new Eudamed registration module will go into effect on December 1, enabling users to create a unique single registration number (SRN). Read More
In further Brexit fallout, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) said Sept. 1 that devices with the CE mark will continue to enjoy UK recognition until June 30, 2023. Read More
"The clinical experience generated during this initial study phase will be critical for the future of the therapy, as many of these patients are not good candidates for traditional surgical tricuspid valve interventions due to their poor right-heart functions," said Vinayak Bapat, the study’s co-principal investigator. Read More