Planmed Oy said yesterday it won FDA approval for its Planmed Clarity 2D full-field digital mammography system. The company said the Clarity 2D system is designed to provide improved image quality, optimal ergonomics and usability for breast cancer screenings. The system also supports diagnostic work-up examinations and biopsy procedures, Planmed said. “We are excited that […]
Planmed
FDA approves first endovascular grafts for aortic tears | Regulatory Roundup
The FDA granted W.L. Gore & Associates the first U.S. clearance for using an endovascular graft to treat tears or ruptures in the aortic wall.
Gore’s Conformable TAG thoracic endoprosthesis was approved as a treatment for a transection or tear in the aortic wall, an injury typically the result of a car accident, crushing of the chest or a fall from a high place, according to an FDA release.