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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
Siemens Healthcare Diagnostics delayed responding to complaints about several of its devices not working properly for months on 12 occasions and also delayed notifying the FDA and correcting the problems. Read More
The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Read More
Reauthorization of FDA’s user fee legislation moved ahead a step last week as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee agreed to include a slimmed-down version of user fee legislation and smaller policy riders on a short-term government funding bill, or continuing resolution (CR). Read More
The UK-based company is focused on the development of novel therapies to treat swallowing disorders caused by diseases of the central and peripheral nervous system. Read More