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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
The Model 450 achieved a 99.99 percent kill of MS2 bacteriophage — an accepted SARS-CoV-2 surrogate — as well as a 99.99 percent kill of mold and bacterial spores, the company said. 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
If a device sponsor wishes to appeal a rejection from the FDA’s Center for Devices and Radiological Health (CDRH), it should follow the chain of command to the next level up from the official who made the decision, the agency said in a final guidance released yesterday. Read More