Device company Stryker has agreed to pay $7.8m and to hire a consultant to examine its record-keeping procedures in a settlement of SEC allegations that the company’s subsidiaries in India, China and Kuwait violated the Foreign Corrupt Practices Act.
Stryker Corp. has agreed to pay the US Securities and Exchange Commission $7.8m to resolve allegations the company had violated the Foreign Corrupt Practices Act.
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Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
