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Medtronic’s June recall of its Mahurkar Acute Triple Lumen and Mahurkar Acute High Pressure Triple Lumen Catheters, the third recall of the company’s hemodialysis catheters in a year, has been deemed class I by the FDA, because use of the device could cause serious injury or death. Read More
Recent clearances and approvals of medical devices include not just new versions of existing products, but entirely different ways to provide care for both complex illnesses and common needs. Read More
Make sure to submit electronic or written comments on a guidance by the closing date is the first tip given by CDRH in a list, released Aug. 16, of tips, recommendations and instructions on how to submit comments on a guidance. Read More
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