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Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and a webinar from FDAnews, a WCG company on medical device risk management tools. Read More
This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made on an Entresto podcast and comments on the EU proposal for compulsory licensing. Read More
The FDA has classified the most recent recall of certain Philips Trilogy ventilators as class I, the most serious type of recall as use of the device may lead to serious injury or death. Read More
Incorporating off-the-shelf (OTS) software into medical devices is becoming more common but a new guidance from the FDA advises that when using prepared software from another manufacturer, devicemakers still bear responsibility for continued safe and effective performance of the device. Read More
Illumina received notice in July that the Securities and Exchange Commission (SEC) was conducting an investigation into the company’s acquisition of Grail, requesting documents from the company over the beleaguered acquisition. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
In July, the court said that PTAB used incorrect legal framing and conducted an erroneous obviousness analysis in its opinion on separate but related Medtronic patents. Read More
Extended timelines alone are not sufficient to achieve transition to the new European medical device regulations, Team NB — the European Association of Medical devices Notified Bodies — says in a position paper it issued Thursday, explaining that manufacturers are still lagging in applying for certification. Read More
New resources are needed to support CMS’s Coverage and Analysis Group’s coverage decisions for FDA-approved breakthrough medical devices, says a new report from AdvaMed and Health Management Associates, to decrease the review time for medical devices. Read More