Women May Face Additional Risks From LAAO Treatment, FDA Cautions
The US agency issued a letter to providers in the wake of a study that found significantly higher complication rates in women implanted with Boston Scientific’s Watchman device.
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June, July and August brought a number of important new approvals and trial announcements from the major cardiac device companies. Here are some of the highlights you might have missed during the summer.
The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.
The agency asked consultants Booz Allen Hamilton to evaluate its handling of diagnostic EUAs as a way to prepare for potential future pandemics.