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Listen to the editor's page of the March 18th JACC issue, Harlan M. Krumholz, MD, SM, and Kushal T Kadakia, MSc, examine the troubled history of the Select IVC filter, a device approved by the FDA in 2007, which was later linked to severe safety issues due to clinical trial misconduct and regulatory oversights. In this audio version of their page, they note that the case reveals systemic vulnerabilities in medical research, regulation, and publication practices, emphasizing the importance of transparency, rigorous oversight, and ethical conduct in medical device development. They propose key actions for regulators, industry, medical journals, and clinicians to improve patient safety, trust, and the integrity of medical research.
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Listen to the editor's page of the March 18th JACC issue, Harlan M. Krumholz, MD, SM, and Kushal T Kadakia, MSc, examine the troubled history of the Select IVC filter, a device approved by the FDA in 2007, which was later linked to severe safety issues due to clinical trial misconduct and regulatory oversights. In this audio version of their page, they note that the case reveals systemic vulnerabilities in medical research, regulation, and publication practices, emphasizing the importance of transparency, rigorous oversight, and ethical conduct in medical device development. They propose key actions for regulators, industry, medical journals, and clinicians to improve patient safety, trust, and the integrity of medical research.
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