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Five device manufacturers landed Form 483s from the FDA over their handling of complaints, medical device reporting, and corrective and preventive actions, among other deviations. Read More
The World Health Organization is developing an Essential Diagnostics List to help countries create their own national lists of essential diagnostic tests and tools. Read More
Medical device manufacturers expect strong sales growth in the U.S. and Europe this year but they are less enthusiastic about China and other developing markets. Read More
The U.S. could become a more attractive place than the EU to introduce new medical devices given the more stringent premarket clinical data requirements… Read More
The International Medical Device Regulators Form has proposed a new system for reporting adverse events related to medical devices that will provide consistency for and reduce the burden on manufacturers. Read More
Members of the medtech industry concerned that EU device regulations expected this summer will conflict with aspects of the new version of ISO 13485 can rest easy, one expert says. Read More
Cook Medical initiated a global recall of its Beacon Tip catheters, following reports of degrading polymer in the catheter tips, which may lead to fracture or separation. Read More
Aiming to improve the safety of medical device connections in clinical settings, ISO has published a new standard on neuraxial applications for small bore-connectors. Read More
Two House members are calling on HHS Secretary Sylvia Burwell to provide more details of how the department is responding to the Zika outbreak, saying the current status of diagnostic testing for the virus is alarming. Read More