Medical device maker Trivascular won premarket approval for its Ovation stent graft system, almost precisely 1 year after the FDA granted the device approval under the humanitarian use device pathway.
GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.
The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.
TriVascular Inc. landed U.S. humanitarian device exemption approval for its Ovation abdominal stent graft system used to repair abdominal aneurysms.
The 20 mm Ovation system was approved by the FDA on Nov. 1 for use in patients with small iliac or femoral artery access of less than 7 millimeters.