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The Food and Drug Administration said it will make the most significant changes in a generation of how the agency clears devices for sale.
Manufacturers fought to get implants back on the market. Regulators gave in. Now thousands of patients are paying the price.
In a world full of dizzying innovation, marketing blitzes and conflicts of interest, doctors and patients must decide: how much risk is too much?
Government regulators, industry lobbyists and medical experts scrambled to get ahead of ICIJ’s latest investigation, the Implant Files, before the first word was even published.
ICIJ partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored.
A global investigation reveals the rising human toll of lax controls and testing standards pushed by a booming industry.
From garage startup to global dominance, Medtronic bent and broke rules in its relentless pursuit of success.
Confidential injury and malfunction reports have tripled in less than 10 years in many countries