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The FDA is now prioritizing its review of Emergency Use Authorization (EUA) requests on a smaller subset of experienced developers applying for tests that are likely to have either a significant public health benefit or fulfill an unmet need, according to final guidance released by the agency Tuesday. Read More
Artivion’s study of its On-X mechanical aortic valve with the anti-clotting drug apixaban rather than warfarin was halted early for futility. Read More
Observations from the FDA’s Software Precertification Pilot Program confirmed that the rapidly evolving device software category needs a new “regulatory paradigm,” the agency said in a report on the now-completed pilot. Read More
The updated software features new planning tools, workflow tools for gene therapy clinical trials and improved performance, the company said. Read More
In clinical studies, Skout significantly improved adenoma detection in screening and surveillance colonoscopy compared with standard colonoscopy, the company said. Read More
Zuga Medical did not properly investigate hundreds of complaints about failures of its dental implants over a five-year period, the FDA said in a Form 483 issued after a March 24 to April 12 inspection of the company’s Chagrin Falls, Ohio, facility. Read More
The recall is not associated with a June 2021 recall of the company’s BiPAP machines because of an issue with a foam material, the agency noted. Read More