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China’s National Health and Family Planning Commission plans to “blacklist” devicemakers convicted of bribing government officials and ban sales of their products for two years — four for repeat offenses. Read More
CDRH is working on ways to allow devicemakers to use more adult clinical trial data in proving the safety and effectiveness of pediatric devices, center staff said Wednesday. Read More
AdvaMed and Taiwan’s medical device association have signed a memorandum of understanding aimed at supporting medtech innovation and advancing patient care. Read More
A Tuesday appeals court hearing on the Securities and Exchange Commission’s conflict minerals disclosure rule provided no immediate relief for manufacturers — though the line of questioning suggested some judges were sympathetic to industry’s free speech argument against the rule. Read More
Medtech companies could wind up in the crosshairs of U.S. government auditors if the payments they report under the Physician Payment Sunshine Act are frequently disputed by doctors and teaching hospitals. Read More
China’s National Health and Family Planning Commission announced “severe” new measures aimed at barring device- and drugmakers convicted of bribery from selling their products in the domestic market — for as long as four years in some cases. Read More
The UK’s cost-benefit watchdog is recommending that the government pay for operations with a new device that repairs complex aneurysms and dissections of the thoracic aorta, because the technology could reduce the need for additional procedures and the associated risk of serious complications. Read More
Invacare says it has made “significant progress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final certification to the agency. Read More