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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
ArthroCare has agreed to pay a $30 million fine and enter into a deferred prosecution agreement to resolve a U.S. Department of Justice criminal investigation of stock price manipulation. Read More
Ocular Therapeutix’s ReSure Sealant kit won FDA approval last week, making it the gel for sealing small incisions in the eye after cataract surgery. 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
The Central Drugs Standard Control Organization has issued detailed guidance on the registration, reregistration and import of notified in vitro diagnostic kits and on the import of non-notified kits, with the aim of speeding submission reviews and easing the move to electronic submissions. Read More
The FDA Tuesday laid out separate requirements for 510(k)s for over-the-counter and prescription point-of-care blood glucose tests — a shift from current guidance that applies to all blood glucose monitoring systems. 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
Medtronic’s Symplicity renal denervation system for the treatment of uncontrolled hypertension failed to meet a primary endpoint in its U.S. pivotal trial, putting a surprising halt on a technology that had been expected to be a major revenue driver. Read More
Devicemakers must include information on potential pediatric use in most new device submissions under an FDA final rule that takes effect April 10. Read More
SinuSys plans to launch its Vent-OS two-step osmotic expansion sinus dilation system immediately in certain U.S. markets, following receipt of FDA 510(k) clearance. Read More