Medtronic Beats Back Axonics’ Challenge To InterStim Patents
The US patent office has upheld all seven patents at issue, with the verdict on the final three having come on 22 September.
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The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.
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.