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.
Immunodiagnostics developer Oncimmune has inked a contract with Alphabet subsidiary Verily Life Sciences to conduct autoantibody profiling on patients who have developed long COVID-19, defined as a symptomatic case of COVID-19 that lasts for more than four weeks. Read More
The FDA should go ahead with its plans to overhaul its Quality System Regulation (QSR) to harmonize it with the International Organization for Standardization’s ISO 13485 standard, but should give device manufacturers more than one year to implement the revised regulation, industry speakers said at a meeting of the agency’s Device Good Manufacturing Practice Advisory Committee on Wednesday. Read More
To clarify the FDA’s recommendations on quickly and effectively removing potentially harmful drugs and devices from the market, the agency has published a final guidance focused on recall readiness. Read More
Devicemakers must ensure that all equipment used in the manufacturing process meets specified requirements and that it is all appropriately designed, constructed, placed, installed, maintained, adjusted, cleaned and used. Read More
A clinical trial of KidneyIntelX’s Renalytix chronic kidney disease diagnostic tool showed that it can accurately forecast the rate of patients’ decline in kidney function, the company said. Read More
The FDA has extended its review period for AbbVie’s and Boehringer Ingelheim’s Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe Crohn's disease in patients age 16 years and older, calling for details of the injector device. Read More
Irvine, Calif.-based enVVeno Medical has released promising data from a first-in-human study of its VenoValve implant for the treatment of chronic venous insufficiency (CVI). Read More