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January 14, 2019

AdvaMed's Updated Code of Ethics Will Be Effective in 2020

January 14, 2019—The Advanced Medical Technology Association (AdvaMed) announced that its Board of Directors has approved an update of its longstanding Code of Ethics on Interactions With Health Care Professionals (HCPs) in the United States. The revisions will become effective on January 1, 2020, to ensure ample time for stakeholder implementation.

The document is available online here. Also, the updated United States code, along with an overview document and additional information, are available here.

AdvaMed’s original United States code was implemented in 1993, with subsequent updates effective in 2003 and 2009. The code clarifies and distinguishes appropriate activity between HCPs and representatives of AdvaMed member companies, as well as others who adhere to the code. The code has also served as the foundation for other associations’ codes of ethics around the world and for AdvaMed’s Code of Ethics in China, which was launched in 2016, noted AdvaMed.

According to AdvaMed, key changes include:

  • New sections guiding education and marketing programs, communication on safe and effective use of medical technology, and communication on providing technical support
  • Expanded provisions on support for third-party educational and other conferences
  • Clarified and expanded definitions of HCPs and medical technology
  • Revisions to provide additional clarity, definition, and explanation of existing code provisions

In the announcement, AdvaMed President and CEO Scott Whitaker, commented, “The updates reflect evolving legal standards, care delivery models, and best practices over the last decade—since AdvaMed’s last code update in 2008—and are designed to ensure the code’s continued effectiveness as a premier foundational document for ethics and compliance across the medtech industry. These revisions, which also enhance usability and reader-friendliness, reflect our industry’s continued commitment to ethics, integrity, and transparency.”

AdvaMed Chairman Nadim Yared, President and CEO of CVRx, commented, “The industry can stand confidently behind these most recent revisions to the AdvaMed code. By clarifying existing provisions, adding new sections to address additional types of HCP interactions, and further developing the code’s underlying values, the updates anchor the industry in strong compliance principles.”

AdvaMed Chair-Elect Kevin Lobo, Chairman and CEO of Stryker, added, “These updates continue to focus the industry on positive, necessary collaborations with physicians and other HCPs to bring the most effective and innovative care to patients around the world. By helping ensure companies continue to focus on ethical business practices, the refreshed code reinforces the industry’s commitment to delivering expert care and building products that make a difference for health care professionals and patients.”

AdvaMed Ethics & Health Care Compliance Board Committee Chairman Ken Reali, President and CEO of Clinical Innovations LLC, stated, "AdvaMed’s work with global stakeholders to advance ethical business practices and compliance—including through the code updates – benefits the entire medical technology ecosystem and patients everywhere. All medtech companies—from start-ups to large multinationals—can benefit from adopting AdvaMed’s strong and comprehensive code.”

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January 15, 2019

FDA Clears iSchemaView's Rapid Imaging Platform for Use in Selecting Acute Stroke Patients for Thrombectomy

January 15, 2019

FDA Clears iSchemaView's Rapid Imaging Platform for Use in Selecting Acute Stroke Patients for Thrombectomy