We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Eitan Medical’s recall of 1,323 infusion pumps — for a risk that the pump may fail to detect air in the line when running on battery power — has been identified by the FDA as Class I, the most serious type of recall as use of these devices may cause serious injuries or death. Read More
Namandje Bumpus, currently chief scientist for the FDA, will replace Janet Woodcock as principal deputy commissioner, FDA Commissioner Robert Califf announced Wednesday. Read More
Despite overall enthusiasm for the use of multi-cancer diagnostic (MCD) tests, several members of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee raised concerns about the social and emotional risks the technology might carry. Read More
At an FDA advisory committee convened to gather insights on multi-cancer diagnostic (MCD) tests, the 10-member advisory panel veered off course when the topic of endpoints arose, voicing varying levels of support for mortality endpoints in trial design. Read More
The FDA is proposing to classify for the first time certain wound dressings and liquid wound washes containing antimicrobials or other chemicals, an action that would also mean a premarket application (PMA) would be required for some of them. Read More
Vivos Therapeutics achieved a first in obtaining FDA clearance of its removable oral appliance for severe obstructive sleep apnea — an alternative to continuous positive airway pressure (CPAP) or surgical implants — while Philips Respironics deals with potential overheating issues in its DreamStation 2 CPAP devices. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More
This edition of Quick Notes highlights recalls for Excela sodium bicarbonate, sodium chloride and cysteine hydrochloride, Novartis cyclosporin, Bayer larotrectinib, Unomedical VariSoft infusion sets and SoClean CPAP cleaner. Read More