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The FDA’s Neurological Devices Panel will meet April 17 to discuss clinical trial considerations for flow diverters that are intended to treat brain aneurysms. Read More
India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies — a continuation of the rebounding number of studies in the country. Read More
China’s medical device authority released a draft regulation outlining how it will accredit medical institutions that conduct clinical trials for devices. Read More
Sponsors hoping to gain de novo status for new medical device accessories should prepare submissions closely mirroring those for stand-alone devices, the FDA says. Read More
The South Korean government has drafted a regulation that would expand its medical device tracking system to include 24 additional types of products. Read More
House and Senate lawmakers are teaming up on an overhaul of FDA device procedures, including expanding the use of third-party quality audits. Read More
Important details on unique device identification, such as transition times, are missing from the EU’s draft medical device regulation, a major industry group says. Read More