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BioWorld - Monday, January 5, 2026
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Home » FDA says medical device reports for bronchoscopes up, but data too spotty to calculate incidence
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FDA says medical device reports for bronchoscopes up, but data too spotty to calculate incidence

June 28, 2021
By Mark McCarty
The FDA has posted an update on its surveillance of adverse events for bronchoscopes, noting that the number of medical device reports (MDR) has risen to between 100 and 200 such reports per year in the U.S. However, the agency noted that there are half a million procedures performed with these devices each year in the U.S. alone, and that these data are insufficient to infer a specific incidence of adverse events.
BioWorld MedTech Regulatory U.S. FDA

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