The regulator said Becton Dickinson was aware an infusion pump it manufactured had flaws which would prevent it from obtaining approval by the Food and Drug Administration. It continued to sell the Alaris pump without FDA clearance and without informing investors about the regulatory risk to the device, which represented about 10% of the company’s profits in 2019, according to the SEC.
The SEC also said the device maker materially overstated its ...
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