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A second recall of Fresenius Kabi’s Ivenix Infusion System this year has been classified Class I by the FDA due to multiple potentially life-threatening anomalies caused by the device’s version 5.8.0 LVP software. Read More
The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with medical research. Read More
Marketing its cardiac device — intended to treat chronic angina — for un-cleared uses such as growth of new arteries, reduction of COVID-19 symptoms, regeneration of pancreatic tissue, and hair growth has earned Soulaire, a Santa Monica, Calif., devicemaker, an FDA Warning Letter. Read More
CDRH has unveiled a new dataset to help improve chemical characterization methods for biocompatibility of medical devices as part of its efforts to reduce the burden of premarket processes and increase the consistency and transparency of biocompatibility assessment methods. Read More
The Abbott/Thoratec recall of HeartMate II and HeartMate 3 left ventricular assist system (LVAS) has been deemed Class I, the most serious type of recall, by the FDA. Read More
Of the $341 million increase in funding requested for the FDA in President Biden’s FY 2025 budget proposal, $114 million is needed to fund FDA employees’ 5 percent inflation pay increases for both this year and next, according to the agency’s chief financial officer (CFO). Read More
Less than a month after issuing warning letters to a China-based manufacturer of plastic syringes for various quality and branding violations, the FDA is suggesting U.S. providers and consumers avoid the products altogether. Read More